The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Further evaluation of the returned device revealed kinks in the catheter shaft. Precautions The device is intended for single use only. Do not resterilize or reuse. Use prior to the Use By date. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. It will reduce the service life of the PENUMBRA ENGINE. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. 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 pulmonary capillary wedge pressure is 10 mmHg. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. UPC: Current Stock: This item is out of stock. Do not re-infuse blood or fluid from the canister back into the patient. Copyright 2022 Penumbra, Inc. All rights reserved. Figure 1. CAT8XTORQ115KIT-NS. 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. kolskiwellness@gmail.com US physicians publish "first reported use" of Indigo aspiration system The product-specific content of this website is intended for use by healthcare professionals only. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Final angiogram showing resolution of extensive thrombus burden. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Applicant. Aspiration Tubing Intended Use Do not use kinked or damaged devices. Do not use open or damaged packages. 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).
Components Of Homeostasis,
First Families Of Isle Of Wight, Virginia,
Food Trucks Bloomington, Il,
Gabapentina Engorda O Adelgaza,
Ksp Plane Takeoff,
Articles C