MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX96 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX9690BER125
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a medical procedure in the common carotid artery using a benchmark bmx96 access system (bmx96), a neuron select catheter 6f (6f select), a non-penumbra sheath (8f), and a guidewire.It was reported the patient''s anatomy was tortuous and the physician had difficulty accessing the vessel using the bmx96.During the procedure, the physician advanced the bmx96 over the 6f select to the target location against resistance.While retracting the 6f select from the bmx96, the physician experienced resistance, and noticed under fluoroscopy the bmx96 appeared to be fractured near the distal end.Therefore, the physician pulled out the proximal portion of the bmx96 from the patient and the distal portion was removed via vascular surgery.It was reported that resistance was encountered pulling out the proximal portion of the bmx96 from the patient.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK BMX96 ACCESS SYSTEM
• Common Device Name: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17620129
• Report Number: 3005168196-2023-00403
• Device Sequence Number: 7301958
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 01/01/2005

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 Expiration Date: 04/06/2026
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00002526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005