MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX 96 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX9690MSIM125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark bmx96 access system (bmx96) confirmed that the catheter was fractured.The complaint indicated that the bmx96 was torqued and became damaged.If the bmx96 is torqued unrestrained against resistance during use, damage such as a fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed clamp marks and additional fracture on the catheter shaft.Based on the reported complaint, the clamp mark likely occurred during removal of the bmx96 with the sheath using clamps and the additional fracture was intentionally done in order to maintain wire access.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 was undergoing a medical procedure in the right common carotid artery (cca) using a benchmark bmx96 access system (bmx96), a non-penumbra sheath, and a guidewire.During the procedure, the physician advanced the bmx96 and the guidewire into the right cca.The bmx96 was torqued in the common iliac artery and became damaged.The physician was unable to advance a guidewire through the bmx96.The bmx96 then fractured upon retraction but was stuck in the sheath.The physician then decided to remove the bmx96 and the sheath together from the patient.The physician clamped the bmx96 upon removing it with the sheath and made another fracture in order to maintain wire access.The procedure was completed using a new bmx96 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK BMX 96 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: 22092256
• Report Number: 3005168196-2025-00179
• Device Sequence Number: 20559395
• Product Code: DQY
• UDI-Device Identifier: 00815948022683
• UDI-Public: 00815948022683
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: BMX9690MSIM125
• Device Lot Number: H00006590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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
• Patient Age: 84 YR
• Patient Sex: Male