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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the left external carotid artery (eca) using a benchmark delivery 6f 071 catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra microcatheter, and a guidewire.During the procedure, while using the microcatheter and the guidewire to navigate to the target location, the physician noticed a leak in the benchmark.Therefore, the physician decided to remove it.While removing the benchmark with the 5f select inside, the benchmark fractured approximately 5-10cm from the hub.Therefore, the benchmark was not used for the remainder of the procedure.It was reported that the benchmark remained intact by a strand of coil and was removed completely.The procedure was completed using a new benchmark, new 5f select, and the same microcatheter.There was no report of an adverse effect to the patient.
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 confirmed that the catheter was fractured.Based on the damage at the fracture site, this damage likely occurred due to retraction against resistance.If the benchmark is retracted against resistance, damage such as a fracture may occur.This damage may have contributed to the reported leak in the benchmark.Further evaluation revealed support coil winds wrapped around the catheter shaft of the 5f select and kinks on the benchmark.This damage was incidental to the reported complaint and likely occurred from the fractured benchmark.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 6F 071 DELIVERY CATHETER
• 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: 17768091
• Report Number: 3005168196-2023-00433
• Device Sequence Number: 12561074
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 815948025189
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• 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,Followup
• Report Date (Section B): 10/04/2023
• 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: 06/26/2026
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F00007308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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: 38 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005