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

Catalog Number	BMK6F95MBER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure to treat a distal arteriovenous malformation (avm) using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra balloon catheter, and a non-penumbra microcatheter.During the procedure, the physician placed the benchmark in the target location and delivered the balloon catheter using the microcatheter and four vials of embolic agent.Subsequently, the physician removed the benchmark and noticed a perforation at the proximal end.It was reported that the physician was able to maintain stable access throughout the procedure using the benchmark.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed a fracture underneath the strain relief distal to the hub.This is likely the reported damage.If the benchmark is advanced against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an ovalization on the distal shaft.The root cause of this damage could not be determined; however, this damage may have contributed to resistance during advancement.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: 16092205
• Report Number: 3005168196-2022-00609
• Device Sequence Number: 6516822
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 814548014173
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/03/2023
• 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: 07/17/2025
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F00002130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• 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: 12/16/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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: 50 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005