This is potentially more effective than diminished syringe-based aspiration. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. Final angiogram after stent placement showing resolution of underlying disease. Figure 3. Indication For Use gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. J Am Coll Cardiol. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Indigo Aspiration System Intended Use Randomized trial of primary PCI with or without routine manual thrombectomy. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. She was in a rehab facility prior to this new event recovering from her CVA. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Applicant. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Contraindications There are no known contraindications. This is potentially more effective than diminished syringe-based aspiration. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). INDIGO Aspiration Catheters and Separators: Do not use open or damaged packages. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). The Swan-Ganz catheter was exchanged over a long V18 wire. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. CAT RX has allowed us to rethink how we approach these occluded SVGs. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: These pages are not intended for patients or for members of the general public. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Further evaluation of the returned device revealed kinks in the catheter shaft. University of Massachusetts Medical School LIGHTNING Aspiration Tubing Indication for Use The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. The Indigo Separator 4 is not intended for use as a guidewire. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The patient remained on cangrelor with no need for tirofiban. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Contraindications Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Bradenton Cardiology Center/Manatee Memorial Hospital The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. Mechanical thrombectomy was performed. All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. Jolly SS, Cairns JA, Yusuf S, et al. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; hemoptysis; respiratory failure; thromboembolic events. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Precautions The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Final angiogram with complete TIMI 3 flow after the use of CAT RX. suhail.dohad@cshs.org The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Gus Theodos, MD, FACC, FSCAI INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Initial angiography revealed an occlusion of the distal RCA. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . Indigo System Intended Use The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Distal posterior tibial artery emboli occlusion. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. Vascular Thrombectomy. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Mathews SJ, Brown C, Kolski B, et al. Saxon RR, Benenati JF, Teigen C, et al. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). CAT7 and CAT12 are the next generation of the Indigo System catheters. The CAT family of catheters is the foundation of Penumbra's Indigo System. The results may vary depending on a variety of patient specific attributes. Equipment is not safe for MR use. gtag('js', new Date()); Kingsport, Tennessee Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. UMassMemorial University Campus If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Do not resterilize or reuse. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Contraindications Otherwise, this could result in degradation of the performance of this equipment. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Circulation. Related Items. Potential Adverse Events indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). 1. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Potential Adverse Events Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. 2017;377:2240-2252. 2. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Do not use open or damaged packages. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Potential Adverse Events There were no cases of 30-day cardiovascular death or post procedural stroke. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Return all damaged devices and packaging to the manufacturer/ distributor. N Engl J Med. Lightning comes packaged with the Indigo CAT7 or CAT12. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo Aspiration System is contraindicated in: Indication For Use There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 5 and 94. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The device is intended for single use only. Do not use in oxygen rich environment. Created with Sketch. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. No modification of this equipment is allowed. Prior to use, please consult device labeling and instructions for use. Return all damaged devices and packaging to the manufacturer/distributor. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Initial angiogram showing high thrombus burden in the left circumflex artery. K180412. Brian Kolski, MD Do not resterilize or reuse. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Missouri Baptist Medical Center The CAT8 is indicated for removal of emboli and thrombi from the peripheral . S. Jay Mathews, MD, MS, FACC Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Orange, California Director, Structural Heart In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Contraindications There are no contraindications. Copyright 2023 Penumbra, Inc. All rights reserved. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. There are no contraindications. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. TIMI 3 flow was achieved in 88% of cases. INDIGO Aspiration Tubing: function gtag(){dataLayer.push(arguments);} Worcester, Massachusetts The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. 0, 24. After one pass with CAT RX, the initial occlusion was removed. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Conclusions: evaluation of the cat8 revealed that the device was fractured. Catheters & Separators. Penumbra Aspiration Pump: Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. . Do not use in an oxygen rich environment. sjaymathewsmd@gmail.com Saint Louis, Missouri Do not block bottom or back air vents. Separator 8, 150 cm Length, 0.072 in. Do not use in oxygen rich environment. IN-DATE. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Potential Adverse Events Figure 3. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Tareq Kass-Hout. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The means of mains disconnect is to remove the power cord. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. Do not use kinked or damaged devices. Contraindications Not for use in the coronaries or the neurovasculature. 510 (k) Number. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. right-arrow Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. J Vasc Interv Radiol. CAT RX is an essential tool in our percutaneous coronary armamentarium. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 2. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events.