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

Model Number 5MAXJET7KIT-B

Device Problem Material Deformation (2976)

Patient Problems Death (1802); Fistula (1862)

Event Date 10/30/2020

Event Type  Death  

Manufacturer Narrative

The product was not returned for evaluation as it was disposed of at the end of the procedure.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.This report is associated with user facility report (b)(4).

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), velocity delivery microcatheter (velocity), non-penumbra stent retriever (trevo), an occlusion balloon (stryker 3mm transform occlusion balloon), and wire (synchro 14).During the procedure, the physician made a first pass in the target vessel with the jet7 and a stent retriever using combination technique.The jet7 was navigated over a wire and to the m1 segment.The velocity was then passed through the clot, and the wire was removed.Next, the stent retriever was passed through the velocity under continuous saline flush and deployed into the clot.After a dwell time of five minutes, the stent retriever was pulled towards the jet7 to trap the clot between the jet7 and stent retriever.Following a successful trap and pull of the clot, the physician was removing the jet7 and the stent retriever as a system.However, as the stent retriever was completely retracted into the jet7, the physician decided to retract the stent retriever through the length of the jet7.After the stent retriever was removed, the physician aspirated the blood into a 20cc syringe to clear the lumen of the jet7.Subsequently, the physician injected contrast through the jet7.The contrast injection confirmed that clot was still occlusive in the m1 segment.The physician made a second pass in the target vessel with jet7 using the adapt technique.After two minutes of aspiration, the jet7 was slowly retracted under continuous aspiration.The jet7 was occluded until passing through the carotid terminus.At this point, blood return was observed, and the physician stopped retracting the jet7.The physician aspirated with a 20cc syringe confirming blood return without resistance.A contrast injection was again administered through the jet7.The physician then advanced a balloon to perform angioplasty within the vasculature.Following this attempt, the physician removed the devices from the patient.Upon removal of the jet7, the physician noted that the catheter had coil winds exposed near the distal end of the device.Subsequently, the physician performed a contrast injection through the guide catheter which revealed a carotid cavernous fistula and bleed into the cavernous sinus.To occlude the carotid artery and stop the bleeding, the physician performed a coil embolization procedure in the cavernous carotid segment using a px slim delivery microcatheter (px slim) and penumbra coils 400 (pc400s).The coil embolization procedure was successful, and the carotid artery was occluded.The patient then experienced progression of the left hemispheric ischemic stroke causing midline shift.The patient was placed on comfort care and died two days later.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report 3005168196-2020-02116: 1.Outcomes attributed to adverse event; date of death.2.Type of reportable event.3.Placeholder.

• 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: 10909735
• MDR Text Key: 219381731
• Report Number: 3005168196-2020-02116
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR