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

Catalog Number	BMK6F105BER130
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, the physician advanced the benchmark over the guidewire to the subclavian artery.The physician then removed the guidewire to flush the benchmark and subsequently noticed that the proximal end of the benchmark was fractured.Therefore, the benchmark was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 07/12/2023: section b.Box 5.Describe event or problem; section h.Box 6.Device code 2.Evaluation of the returned benchmark confirmed a fracture on the proximal end.If the device is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an ovalization on the distal end.If the device is forcefully pinched or gripped during use, damage such as an ovalization may occur.This damage may contribute to resistance during advancement and retraction.Forceful manipulation against this resistance may have contributed to the fracture on the proximal shaft.Evaluation also revealed kinks on the distal shaft.These kinks were likely incidental to the reported complaint.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 basilar artery using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, the physician experienced resistance while advancing the benchmark over the guidewire to the subclavian artery.The physician then removed the guidewire to flush the benchmark and subsequently noticed that the proximal end of the benchmark was fractured.Therefore, the benchmark was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.

• 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: 17375034
• Report Number: 3005168196-2023-00347
• Device Sequence Number: 7061629
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 814548014029
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023
• 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: 07/10/2025
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F00001999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005