cat8 penumbra catheter

Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Do not use in oxygen rich environment. Do not resterilize or reuse. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. Gus Theodos, MD, FACC, FSCAI Suhail Dohad, MD, FACC Alameda, CA 94502. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Brian Kolski, MD Figure 3. 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: Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 2018;29:92-100. Precautions 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). LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Penumbra Announces U.S. Commercial Availability of INDIGO System Interventional Cardiology When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Indication For Use skin is red but turns white when pressed Figure 2. Potential Adverse Events INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Otherwise, this could result in degradation of the performance of this equipment. Next Article Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not use open or damaged packages. 0, 24. 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Indigo System Catheters & Separators | Penumbra Inc The canister is intended for single use only. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. 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. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. She was in a rehab facility prior to this new event recovering from her CVA. The Indigo System and CAT8 - Endovascular Today Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. INDIGO System LIGHTNING Aspiration Tubing Intended Use Indigo System | Penumbra Inc For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Figure 2. (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. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Potential Adverse Events Warnings/Precautions The canister is intended for single use only. 510 (k) Number. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC 1. Do not use in oxygen rich environment. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Kingsport, Tennessee INDIGO Aspiration System Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The penumbra cat8 indigo system (cat8) was kinked approximately 4. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 How Penumbra's smart-sucking algorithms and catheters speed up clot TIMI 3 flow was achieved in 88% of cases. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. window.dataLayer = window.dataLayer || []; Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Lightning comes packaged with the Indigo CAT7 or CAT12. 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; 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . 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. Related Items. Rethinking Thrombus Removal With the Indigo System: Introducing The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. University of Massachusetts Medical School sjaymathewsmd@gmail.com Indigo System | Computer-Aided Mechanical Aspiration. Use prior to the Use By date. Possible complications include, but are not limited to, the following: Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Order Qty. 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. Figure 3. Final angiogram showing resolution of extensive thrombus burden. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The CAT family of catheters is the foundation of Penumbras Indigo System. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. window.dataLayer = window.dataLayer || []; Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . The product-specific content of this website is intended for use by healthcare professionals only. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. To prevent fire or shock hazard, use a replacement power cord of equal rating. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Only use replacement fuse with correct rating (see Table 1 for fuse rating). Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. chronic clot, atherosclerotic plaque) The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy.

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