MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Fistula (1862)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, arteriovenous fistula, vessel spasm, thrombosis, dissection or perforation, including death. Therefore, it was determined that the reported adverse event was an anticipated complication. The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a non-penumbra revascularization device. During the procedure, upon completion of the third pass using the jet7 and revascularization device, resistance was encountered while retracting the non-penumbra stent retriever. After removing the stent retriever, the physician performed an angiogram that revealed a vessel injury. The jet7 was then removed and the physician realized it was split open at the distal end. It was also reported that upon removal of the jet7, the patient's head turned as if reacting to pain. The procedure was continued using another jet7, the same microcatheter, and a non-penumbra stent retriever. Although the patient had remaining clot in the mca after the fourth pass, the physician decided it was too risky to continue and ended the procedure. The following day, another procedure was performed to embolize the fistula using penumbra coil 400s (pc400s). The medical status of the patient is unknown.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 9960106
• MDR Text Key: 187696637
• Report Number: 3005168196-2020-00548
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (Y/N): Y
• Reporter Country Code: US
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/16/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/14/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device LOT Number: F94084
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report TO Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 04/14/2020 Patient Sequence Number: 1