MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72SDKIT
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a sendit delivery device (sendit), a non-penumbra sheath, a non-penumbra microcatheter, and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, while advancing the red72, the physician experienced resistance.Therefore, the physician decided to remove the red72.While retracting the red72, the physician experienced resistance and stretched and fractured the red72 at the distal end.It was reported that the sheath became kinked and pinched the red72 due to the tortuous anatomy.The procedure was completed using a penumbra system red 62 reperfusion catheter (red62) and the benchmark bmx96 access system (bmx96).It was reported that the fractured distal end of the red72 was removed using a snare device at a later date.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed stretching and a fracture on the catheter's distal shaft.If the device is retracted against resistance during use, damage such as this may occur.The reported tortuous patient¿s anatomy and kink on the non-penumbra catheter likely contributed to resistance during the procedure.Further evaluation revealed that the distal tip was crimped with a metal material.This was likely incidental to the reported complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Common Device Name: 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: 20162168
• Report Number: 3005168196-2024-00309
• Device Sequence Number: 17950835
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00011018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005