MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY, QJP

Catalog Number	BMK6F95BER120
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the anterior cerebral artery using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra microcatheter, non-penumbra coils, and a guidewire.During the procedure, the benchmark was advanced into the petrous segment of the internal carotid artery (ica).The physician advanced the microcatheter over a guidewire and placed four coils in the target location.An angiography was performed after placing the fourth coil.The physician repositioned the benchmark and performed a contrast run but noticed that contrast would not reach to the distal end of the benchmark.It was reported that contrast was leaking out from the proximal end of the benchmark.The physician attempted to remove the benchmark, but experienced resistance, and noticed the benchmark had fractured by the hub.After making further attempts, the physician was able to remove the benchmark.The benchmark was fractured at multiple locations and remained connected by the inner wire.All segments of the benchmark were successfully removed from the patient.The procedure was completed using two additional non-penumbra coils, and a non-penumbra guide sheath.There was no report of an effect to the patient.
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.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• 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: 21097773
• Report Number: 3005168196-2025-00009
• Device Sequence Number: 20996991
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 00815948025189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: BMK6F95BER120
• Device Lot Number: F00013061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: 78 YR
• Patient Sex: Male