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

Catalog Number	BMK6F95M
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra 8f introducer sheath.During the procedure, while advancing the benchmark using its peel away sheath through the introducer sheath, the physician experienced difficulty.After advancing the benchmark approximately fifty centimeters, the physician experienced resistance, and the benchmark stopped advancing.The physician experienced difficulty while attempting to remove the benchmark and fractured the benchmark.Therefore, the introducer sheath containing the fractured segment of 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 section was updated: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned benchmark 6f 071 delivery catheter (benchmark) confirmed that the catheter was fractured and revealed ovalization on the fractured location.If the benchmark is advanced against resistance during use, damage such as an ovalization may occur.This damage may have contributed to additional resistance during removal of benchmark and likely caused the device to fracture.The root cause of initial resistance during the procedure could not be determined.Further evaluation revealed additional ovalization on the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.During evaluation, a demonstration benchmark was advanced through the returned non-penumbra introducer sheath without an issue.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 medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra 6f introducer sheath.During the procedure, while advancing the benchmark using its peel away sheath through the introducer sheath, the physician experienced difficulty.After advancing the benchmark approximately fifty centimeters, the physician experienced resistance, and the benchmark stopped advancing.The physician experienced difficulty while attempting to remove the benchmark and fractured the benchmark.Therefore, the introducer sheath containing the fractured segment of 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21150396
• Report Number: 3005168196-2025-00014
• Device Sequence Number: 9134577
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2025

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: BMK6F95M
• Device Lot Number: F00011313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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 Sex: Unknown