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

Catalog Number	BMK6F95MBER120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
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), a non-penumbra microcatheter, a non-penumbra sheath (6f), non-penumbra coils, and liquid embolic agents.During the procedure, the physician successfully placed four or five coils in the target location.Upon removal of the microcatheter and benchmark, the physician found that the benchmark had fractured mid-shaft.It was noted that the fractured segment of the benchmark was within the aorta.The physician used a snare device to successfully retrieve the fractured segment of the benchmark from the patient.The procedure was considered completed.There was no report of an adverse effect on the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark 6f 071 delivery catheter (benchmark) confirmed a catheter fracture.It was reported that the fracture occurred during removal of the benchmark from the procedure.If the benchmark is retracted against resistance during use, damage such as this may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed multiple kinks, ovalization, and stretching on the catheter shaft.This damage was incidental to the reported complaint.The damage likely occurred while snaring, handling post-procedure, or packaging for return.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, QJP
• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24592241
• Report Number: 3005168196-2026-00073
• Device Sequence Number: 21066112
• Product Code: DQY
• UDI-Device Identifier: 00815948025202
• UDI-Public: 00815948025202
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/13/2026

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: F00018717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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: 75 YR
• Patient Sex: Male