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

Catalog Number	BMK6F95MBER120
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark) and a neuron select catheter 5f (5f select).During the procedure, while advancing the 5f select through the benchmark, the physician experienced resistance.The physician noticed that the benchmark fractured.Therefore, the 5f select and proximal portion of the benchmark were removed.After a few attempts, the physician successfully removed the distal part of the benchmark using a snare device.The procedure had ended at this point.There was no report of an adverse effect on the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.If the benchmark is manipulated against resistance, damage such as a kink and subsequent fracture may occur.The root cause of the resistance during procedure could not be determined.Further evaluation revealed kinks along the catheter shaft.This damage was likely incidental to the reported complaint and may have occurred during snaring for removal or handling post-procedure.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21339825
• Report Number: 3005168196-2025-00036
• Device Sequence Number: 3826738
• Product Code: DQY
• UDI-Device Identifier: 00815948025202
• UDI-Public: 00815948025202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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 Catalogue Number: BMK6F95MBER120
• Device Lot Number: F00013894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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: 80 YR
• Patient Sex: Female