MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX81 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX7F105
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
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.Placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle meningeal artery using a benchmark bmx81 access system (bmx81) and a non-penumbra sheath (7fr).During the procedure, the physician accessed the target vessel through the right radial artery and administered medications (verapamil, nitroglycerin, and heparin).After placing the sheath, the bmx81 was advanced into the vessel.While advancing the bmx81 into the vessel, the physician encountered resistance and decided to remove the bmx81.After removal, the physician noticed that the bmx81 had fractured on the distal end near the markerband.It was noted that the tip of the bmx81 had moved into an adjacent artery.After assessing with a second physician, it was decided to leave the fractured tip in the patient''s vessel.The procedure was completed with a new bmx81 with right femoral access.
Additional Manufacturer Narrative
Evaluation of the returned bmx81 confirmed it was fractured.Evaluation revealed stretching and kinks proximal to the fractured location.This type of damage such as stretching, kinks, and fracture at the distal end typically occurs if the bmx81 is retracted against resistance.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed ovalization and an additional kink on the proximal shaft.This damage was incidental to the complaint, and the root cause could not be determined.Penumbra devices are visually 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: BENCHMARK BMX81 ACCESS SYSTEM
• Common Device Name: DQY, QJP
• 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: 20377689
• Report Number: 3005168196-2024-00337
• Device Sequence Number: 11698854
• Product Code: DQY
• UDI-Device Identifier: 00815948024601
• UDI-Public: 00815948024601
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221822
• 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): 10/16/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Catalogue Number: BMX7F105
• Device Lot Number: F00007988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005