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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed a kink near the hub and confirmed a leak.If the device is mishandled upon removal from its packaging, damage such as a kink may occur.During evaluation, the benchmark was flushed with air while submerged, and a leak was observed coming from beneath the strain relief.Upon unraveling the strain relief, a partial break was observed in the catheter.Further evaluation revealed a distal ovalization.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra sheath and a guidewire.During the procedure, after loading the 5f select into the benchmark and over the guidewire, the physician noticed a hole at the proximal end of the benchmark while advancing the benchmark in the patient.Therefore, the benchmark was removed.The procedure was completed using a new benchmark, the same 5f select, the same sheath and the same guidewire.There was no report of an effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: section h.Box 3.Device evaluated by manufacturer? section h.Box 3.Device returned to manufacturer? h3 other text : placeholder.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• 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: 16615152
• Report Number: 3005168196-2023-00133
• Device Sequence Number: 20401404
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 814548014128
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/04/2023
• 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: 09/12/2025
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F00003022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• 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: 01/28/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005