MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX 81 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX7F95
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/31/2025
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 middle cerebral artery (mca) using a benchmark bmx 81 access system (bmx81) and a penumbra system red 62 reperfusion catheter (red62).During the procedure, the physician made the first pass in the target location using the red62.After the pass, the red62 was removed to be flushed, and the physician noticed the bmx81 distal end became occlusive to the vessel and dissected the petrous segment of the internal carotid artery (ica).The physician placed a stent in the carotid.The procedure was completed using a penumbra system red 43 reperfusion catheter (red43).
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Evaluation of the returned benchmark bmx 81 access system (bmx81) revealed an undamaged and functional device.Based on the reported event, the bmx81 was in a target anatomy that was too small for its intended use, resulting in the vessel dissection.There was no reported malfunction of the device.Further evaluation revealed bends along the length of the catheter shaft.This damage is likely incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.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: BENCHMARK BMX 81 ACCESS SYSTEM
• Common Device Name: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22946461
• Report Number: 3005168196-2025-00280
• Device Sequence Number: 9257627
• Product Code: DQY
• UDI-Device Identifier: 00815948024663
• UDI-Public: 00815948024663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BMX7F95
• Device Lot Number: F00015590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 34 YR
• Patient Sex: Male