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

Catalog Number	BMK6F105MBER130
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, after a few minutes of use, the physician noticed leaking from a hole at the proximal end of the benchmark.Therefore; the benchmark was removed.The procedure was completed with a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a leak beneath the stain relief.Evaluation revealed a fracture underneath the strain relief.If the benchmark is manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.This damage likely contributed to the reported complaint during the procedure.Further evaluation revealed a distal shaft ovalization.This damage was likely incidental to the 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.

• 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: 15820484
• Report Number: 3005168196-2022-00537
• Device Sequence Number: 16916517
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 814548014050
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 11/17/2022
• 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: 11/18/2024
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F110935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• 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: 03/18/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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: 49 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005