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

Catalog Number	BMX7F105
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy in the common carotid artery (cca) using a benchmark bmx81 access system (bmx81), a non-penumbra sheath (7f), a non-penumbra aspiration catheter, and a guidewire.During the procedure, the physician gained access to the radial artery using the sheath.While advancing the bmx81 through the sheath over the guidewire toward the subclavian artery, the physician experienced resistance.It was noted that the physician was able to advance the bmx81 to the cca.The physician then advanced the aspiration catheter through the bmx81 over the guidewire to the target location and performed aspiration.After completion of the procedure, the physician removed the aspiration catheter.While removing the bmx81 from the patient's body, the physician experienced resistance and noticed that the bmx81 became damaged at the midshaft outside of the patient's body.The physician then used a hemostat to clamp the bmx81 and the sheath together to prevent air from entering.While slowly removing the bmx81 and the sheath using the hemostat, the physician experienced resistance and noticed that the radial artery came out along with the damaged bmx81.The physician held pressure and a vascular physican performed a surgical repair of the radial artery.The procedure was completed at this point and the patient is recovering well.
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.
Additional Manufacturer Narrative
Evaluation of the returned benchmark bmx81 access system (bmx81) revealed that the catheter was fractured.Based on the reported event, the bmx81 was not fractured upon removal from the patient; therefore, the fracture was likely incidental and occurred after the procedure.The damage visualized at the end of the procedure during device removal was likely stretching due to retraction of bmx81 against resistance.It was reported that a radial cocktail was not administered.This likely led to a vasospasm causing the resistance experienced during device removal and subsequent damage to the patient vessel and bmx81.If a vessel is experiencing severe vasospasm, resistance and subsequent damage to the patient vessel and device may result.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: 23073868
• Report Number: 3005168196-2025-00301
• Device Sequence Number: 20075226
• Product Code: DQY
• UDI-Device Identifier: 00815948024601
• UDI-Public: 00815948024601
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/06/2025

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 Expiration Date: 08/20/2026
• Device Catalogue Number: BMX7F105
• Device Lot Number: F00008086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female