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

Catalog Number	BMK6F105M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra sheath (6f), and a guidewire.During the procedure, the physician experienced difficulty while attempting to withdraw the 5f select and decided to remove it with the benchmark.Upon removal, it was noted that the benchmark had fractured at the mid-shaft and the 5f select was stuck inside the benchmark.Therefore, the benchmark and 5f select were no longer used for the remainder of the procedure.The procedure was completed using a neuron max 6f 088 long sheath (neuron max) and a neuron select catheter 6f (6f select).There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
The following sections were updated: 1.Section b.Box 5.Describe event or problem 2.Section h.Box 6.Health effect impact code 2 evaluation of the returned benchmark 6f 071 delivery catheter (benchmark) confirmed that the benchmark was fractured and revealed coil winds wrapped around the 5f select catheter shaft.If the benchmark is retracted against resistance, damage such as a fracture may occur.The root cause of resistance during the procedure could not be determined.This damage likely contributed to the inability to retract the 5f select 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.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra sheath, and a guidewire.During the procedure, the physician experienced difficulty while attempting to retract the 5f select and decided to remove it with the benchmark.Upon removal of the 5f select and benchmark, it was noted that the benchmark had fractured.The physician then used a snare device to successfully retrieve the fractured segment of the benchmark from the patient.The procedure was completed using a neuron max 6f 088 long sheath (neuron max) and a neuron select catheter 6f (6f select).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: 21953806
• Report Number: 3005168196-2025-00150
• Device Sequence Number: 18406114
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2025

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: BMK6F105M
• Device Lot Number: F00013482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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