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

Catalog Number	BMK6F95BER120
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
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 in the internal carotid artery using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra sheath (6f), a non-penumbra balloon catheter (0.014" 4mm x 40mm 142cm), and a guidewire (0.035 250cm).It was reported that there was stenosis in the ica.The physician gained trans-radial access using the sheath.It was noted that a radial cocktail of verapamil and heparin was administered prior to the procedure.The physician advanced the benchmark and the balloon catheter through the sheath to the target location and performed balloon angioplasty.The balloon catheter was removed.While retracting the benchmark, resistance was encountered, resulting in a fracture within the brachial artery.A vasospasm was observed in the same vessel.Nitroglycerin was administered to treat the vasospasm; however, the event was not resolved.The physician attempted to retract the benchmark, but the benchmark could not be removed.The physician decided to cut the benchmark at the radial access site.The patient was transferred for surgical cut down.The benchmark was successfully removed from the patient.It was reported that the physician believed the vasospasm may have contributed to the fracture of the benchmark.
Additional Manufacturer Narrative
Evaluation of the returned benchmark 6f 071 delivery catheter (benchmark) confirmed that the catheter was fractured and revealed stretching throughout the catheter shaft.If the benchmark is retracted against resistance, damage such as stretching and a subsequent fracture may occur.The reported vasospasm in the brachial artery may have contributed to resistance during the procedure.Further evaluation revealed multiple ovalizations and an additional fracture.This damage was incidental to the reported complaint and likely occurred during removal from the patient.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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23543903
• Report Number: 3005168196-2025-00363
• Device Sequence Number: 18585898
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 00815948025189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/04/2025

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: F00017032
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: 57 YR
• Patient Sex: Female