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

Catalog Number	BMK6F105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the anterior communicating artery (acom) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra long sheath, and a guidewire.During the procedure, while advancing the benchmark through the long sheath, the physician observed under fluoroscopy that the markerband of the benchmark fractured within the long sheath and migrated into the middle cerebral artery (mca).Therefore, the benchmark was removed.The physician decided not to remove the marker band from the mca since it was not obstructing the flow.The procedure was completed using a non-penumbra catheter and the same long sheath.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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) could not confirm the reported complaint.Benchmark has a markercoil on its distal end for radio opacity, not a markerband.The markercoil was intact and no material was observed to be missing from the returned benchmark.The root cause of the reported complaint could not be determined.Further evaluation revealed that the benchmark had bends and was ovalized near its distal end.This damage was incidental to the reported complaint, and the root cause could not be determined.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.Note: although the initial complaint indicated that the benchmark 6f 071 delivery catheter (benchmark) markerband was fractured, evaluation of the returned benchmark could not confirm the reported issue.Benchmark has a markercoil on its distal end for radio opacity, not a markerband.The markercoil was intact and no material was observed to be missing from the returned benchmark.Further evaluation revealed that the benchmark had bends and was ovalized near its distal end.If this malfunction were to recur, it would not cause or contribute to a serious injury or death.Therefore, this event is considered not reportable against the benchmark.
Event or Problem Description
The patient was undergoing a medical procedure in the anterior communicating artery (acom) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra long sheath (ballast), and a guidewire (.035 inch).During the procedure, while advancing the benchmark through the long sheath, the physician observed under fluoroscopy that a distal marker had migrated into the middle cerebral artery (mca).It was believed that of the distal marker was part of the benchmark.Therefore, the benchmark was removed.The physician decided not to remove the distal marker from the mca since it was not obstructing the flow.The procedure was completed using a non-penumbra catheter and the same long sheath.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: 22984093
• Report Number: 3005168196-2025-00290
• Device Sequence Number: 13119225
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 00814548014012
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/11/2025

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: BMK6F105
• Device Lot Number: F00014334
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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: 48 YR
• Patient Sex: Male