MAUDE Adverse Event Report: PENUMBRA INC. JET 3D REPERFUSION CATHETER SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number JET73DVELSYS

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Fistula (1862); Thrombus (2101)

Event Date 11/25/2019

Event Type  Injury  

Event Description

Penumbra jet7 distal access catheter placed in the left ica for mechanical thrombectomy of left mca thrombus.One pass with stent-triever device performed in the left mca through the jet7 catheter with limited bloodflow improvement in the left mca.Upon 2nd pass with stent-triever device, a fistula from the internal carotid artery to the venous cavernous sinus was noted on angiographic images.Contrast was noted to not be exiting through the tip of the jet7 catheter on the angiographic images as well.The stent-triever and jet7 devices were retracted simultaneously out of the left internal carotid artery, no tension was noted in the system.Upon removal from the guide catheter the jet7 catheter was noticed to have a kink and fracture near the tip, but the catheter was noted to be complete.Per dr (b)(6), the left internal carotid to venous cavernous sinus fistula was created by the fractured catheter, and the left internal carotid artery was embolized from the cavernous segment down to the cervical segment to close the fistula.Also per dr (b)(6), this did not affect the outcome of the procedure for the patient, as there was patent flow across the anterior communicating artery noted with angiography of the right internal carotid artery.

• Brand Name: JET 3D REPERFUSION CATHETER SYSTEM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9468062
• MDR Text Key: 171547467
• Report Number: MW5091662
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JET73DVELSYS
• Device Catalogue Number: JET73DVELSYS
• Device Lot Number: C11200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 59