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

Catalog Number	BMK6F95M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	03/02/2026
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 using a benchmark 6f 071 delivery catheter (benchmark).While using the benchmark the physician observed vasospasms.While attempting to remove the benchmark, the physician experienced difficulty and found that the benchmark fractured in the brachial artery.The fractured benchmark was removed via transfemoral access using a neuron max 6f 088 long sheath (neuron max).No additional information regarding the completion of the procedure was provided.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).The physician inserted the benchmark via transradial access and observed vasospasms.While attempting to remove the benchmark, the physician experienced difficulty and found that the benchmark fractured in the brachial artery.The fractured benchmark was removed via transfemoral access using a neuron max 6f 088 long sheath (neuron max).No additional information regarding the completion of the procedure was provided.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2026-00103: 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.Evaluation revealed stretching at the fracture locations.This indicates that the benchmark likely stretched prior to fracturing.If the benchmark is retracted against resistance, damage such as stretching and subsequent fracture may occur.The reported vasospasm likely caused resistance during retraction.The fracture on the distal length likely occurred during snaring for removal.Further evaluation revealed a kink on the benchmark and stretching on the strain relief.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.

• 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: 24719417
• Report Number: 3005168196-2026-00103
• Device Sequence Number: 6012877
• Product Code: DQY
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: BMK6F95M
• Device Lot Number: F00016750
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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 Sex: Unknown