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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned, and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the subclavian artery using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra catheter, and a non-penumbra sheath.It was reported that the physician used radial access for the procedure.After completion of the procedure, while removing the benchmark, the benchmark fractured.The proximal portion of the benchmark was removed from the radial artery.The physician attempted to retrieve the remaining portion of the benchmark using a snare device but was unsuccessful.On (b)(6) 2026, the remaining portion of the benchmark was removed via surgical cut down using femoral access.
Additional Manufacturer Narrative
Evaluation of the returned benchmark 6f 071 delivery catheter (benchmark) confirmed that it was fractured and revealed a non-penumbra catheter advanced through it.It was reported that the fracture occurred during removal of the benchmark after completion of the procedure.If the benchmark is retracted against resistance, damage such as stretching and a subsequent fracture may occur.Based on the reported complaint and return condition, the root cause of resistance could not be determined.Further evaluation revealed that the distal fractured segment was returned with additional fractures.This damage was likely incidental to the reported complaint and may have occurred during removal of the distal fractured segment during the 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 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: 24284817
• Report Number: 3005168196-2026-00041
• Device Sequence Number: 8318630
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 00815948025189
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F00017828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown