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

Model Number 5MAXJET7KIT-B

Device Problem Break (1069)

Patient Problem Fistula (1862)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system aspiration pump max 110 (pump max), a non-penumbra catheter, a non-penumbra microcatheter, a non-penumbra stent retriever device, and a wire. During the procedure, the physician advanced the jet7, microcatheter and stent retriever device through the neuron max and up to the thrombus. The physician then deployed the stent retriever device, removed the microcatheter and turned on the pump max for aspiration. Subsequently, the stent retriever with the clot was pulled back into the jet7 and removed. With the jet7 in the carotid terminus, the physician did a contrast injection and noticed a carotid-cavernous sinus fistula (ccf). Next, while advancing a wire through the jet7, the wire went out the side of the jet7, and the physician realized that the distal tip of the jet7 was broken and was in the carotid. Therefore, the physician snared out the tip of the jet7 and coiled the ccf. The procedure ended at this point. The ccf was reported to be related to the jet7. The patient is currently recovering from the severe stroke suffered prior to the procedure.

• 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: 10348254
• MDR Text Key: 201233578
• Report Number: 3005168196-2020-01064
• 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: 01/01/2005,07/07/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/30/2020
• 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: F94645
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• 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: 08/06/2020
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 07/30/2020 Patient Sequence Number: 1