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

Catalog Number	BMX96100SIM125
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right common carotid artery using a benchmark bmx96 access system (bmx96), neuron select catheter 6f (6f select), a guidewire and a non-penumbra sheath.During the procedure, the physician experienced resistance while attempting to advance the dilator into the bmx96.The physician then attempted to advance the 6f select into the bmx96 but would still experience resistance.Subsequently, upon inspecting the bmx96, the physician noticed under fluoroscopy the distal end of the bmx96 was fractured.Therefore, the physician advanced a guidewire with another select catheter through the fractured bmx96 and removed the entire bmx96.The procedure was completed using a new bmx96 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned bmx96 confirmed a fracture and revealed signs of torquing at the fractured location.If the device is torqued against resistance, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.The 6f select was removed from the fractured bmx96 with resistance due to the fracture, and the bmx96 from the non-penumbra sheath with resistance due to the fracture.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 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: 18937996
• Report Number: 3005168196-2024-00092
• Device Sequence Number: 15175085
• Product Code: DQY
• UDI-Device Identifier: 00815948022713
• UDI-Public: 815948022713
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/19/2024
• 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: 02/20/2026
• Device Catalogue Number: BMX96100SIM125
• Device Lot Number: H00002223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/20/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Date Report Sent to FDA: 01/01/2005