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

Catalog Number	BMX7F95
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the transverse sigmoid sinus using a benchmark bmx81 access system (bmx81), a stent, and a guidewire.During the procedure, the bmx81 was advanced into the vessel.Next, while advancing a stent through the bmx81 into the vessel, the physician encountered resistance, and the stent became stuck partially outside of the bmx81.While attempting to push the stent out with the guidewire, the physician fractured the bmx81 at the distal end.Therefore, the proximal portion of the bmx81 was removed.A snare was advanced to the vessel to remove the fractured portion of the bmx81; however, the attempts were unsuccessful.The distal portion of the bmx81 was left in the right carotid artery.The procedure had ended at this point.Later, the patient expired due to other complications.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the transverse sigmoid sinus using a benchmark bmx81 access system (bmx81), a stent, and a guidewire.During the procedure, the bmx81 was advanced into the vessel.Next, while advancing a stent through the bmx81 into the vessel, the physician encountered resistance and the stent became stuck partially outside of the bmx81.While attempting to push the stent out of the bmx81, the physician fractured the bmx81 at the distal end.Therefore, the proximal portion of the bmx81 was removed.A snare was advanced to the vessel to remove the fractured portion of the bmx81; however, the attempts were unsuccessful.The distal portion of the bmx81 was left in the right carotid artery.The procedure had ended at this point.Later, the patient expired due to other complications.

• Brand Name: BENCHMARK BMX81 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: 21218354
• Report Number: 3005168196-2025-00023
• Device Sequence Number: 8631184
• Product Code: DQY
• UDI-Device Identifier: 00815948024663
• UDI-Public: 00815948024663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BMX7F95
• Device Lot Number: F00012235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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: 40 YR
• Patient Sex: Female