MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

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.This report is associated with mfr report numbers: 3005168196-2020-01133, 3005168196-2020-01135.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system jet 7 reperfusion catheter (jet7) and a velocity delivery microcatheter (velocity).It was noted that the patient had type iii arch and an anatomy that was very tortuous.During the procedure, the physician advanced the neuron max until it was unable to be advanced beyond the carotid bifurcation.It was noted that the takeoff of the brachiocephalic artery was very tortuous.The physician then advanced the velocity over the jet7 beyond the brachiocephalic artery; but eventually was unable to advance them any further.The physician made several attempts to advance the velocity and jet7 further but were unsuccessful.The physician experienced resistance while attempting to retract the velocity and jet7.Upon removal, it was noticed that the jet7 stretched and the distal tip had broken off.The physician confirmed that the broken piece of the jet7 was lodged within the distal end of the neuron max; therefore, the neuron max containing the broken piece of the jet7 was removed.Upon removal it was noticed that the neuron max was kinked.It was reported that the physician attempted to continue the procedure using a new neuron max, a new jet7 and a new velocity, but was unsuccessful.The physician then attempted to complete the procedure using radial access; however, it was also unsuccessful.It was reported that the attempts were unsuccessful due to how difficult it was to access the target vessel.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET 7 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: 10381128
• MDR Text Key: 202097616
• Report Number: 3005168196-2020-01134
• 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
• Report Date: 01/01/2005,07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95099
• 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: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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 Age: 95 YR