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

Model Number 5MAXJET7-B

Device Problems Stretched (1601); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.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 neuron max 6f 088 long sheath (neuron max), a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra microcatheter and a guidewire.During the procedure, the physician placed the neuron max, advanced the jet7 over the microcatheter and guidewire to the clot, then removed the microcatheter and guidewire.Next, aspiration was initiated; however, after approximately 90 seconds no flow being observed and the jet7 was removed.While flushing the jet7 on the back table, the physician noticed that the distal end of the jet7 expanded.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using a stent retriever device, the same neuron max and microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was sent out for return but the device has not been received by the manufacturer.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda).2.Section h.Box 3: device returned to manufacturer)? 3.Section h.Box 3: device evaluated by manufacturer? the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10377493
• MDR Text Key: 201996181
• Report Number: 3005168196-2020-01125
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (y/n): Y
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F93838
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR