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

Catalog Number	BMX7F95
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark 81 access system (bmx81) confirmed that it was fractured.There was a kink and evidence of torquing at the fractured location.If the bmx81 is kinked and subsequently torqued unrestrained against resistance, damage such as a fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed an unknown material on the catheter.Based on the reported complaint, this damage is incidental to the complaint and the root cause could not be determined.Evaluation also revealed an ovalization near the fracture location and a kink.This damage is incidental to the reported complaint and may have occurred during attempts to remove the device or during packaging 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.
Event or Problem Description
The patient underwent a coil embolization procedure in the anterior communicating artery (acom) using a benchmark 81 access system (bmx81).After completion of the procedure, the physician was removing the bmx81 from the patient and noticed the bmx81 had fractured.Therefore, the physician placed a guidewire through the fractured bmx81 and advanced a neuron select catheter 5f (5f select) over the guidewire and through the fractured bmx81.The fractured bmx81 was then removed together with the 5f select and guidewire as a unit.It was reported that the entire fractured bmx81 was removed, and no part of the bmx81 was left in the patient.The procedure had ended at this point.There was no report of an adverse effect to the patient.

• 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: 23623426
• Report Number: 3005168196-2025-00375
• Device Sequence Number: 13252377
• Product Code: DQY
• UDI-Device Identifier: 00815948024663
• UDI-Public: 00815948024663
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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 Catalogue Number: BMX7F95
• Device Lot Number: H00008337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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
• Patient Age: 56 YR
• Patient Sex: Female