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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
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 coil embolization procedure in the anterior communicating artery (acomm) using a benchmark 6f 071 delivery catheter (benchmark), a sheath, coils, a flow diverter, and a guidewire.During the procedure, the physician positioned the benchmark in the petrous segment of the internal carotid artery (ica).Upon removal at the end of the procedure, it was noted that the benchmark was fractured and the proximal third was retrieved.The physician then gained access in the opposite femoral artery and used a snare device to retrieve the fractured segment of the benchmark.The procedure ended at this point.Due to the patient's dual antiplatelet therapy (dapt), the physician was unable to use an angioseal and instead applied prolonged manual pressure to the groin.There was no report of an adverse effect on the patient.
Additional Manufacturer Narrative
The following section was updated: 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.Based on the lack of stretching at the fracture location, it was likely the result of a kink.If the benchmark is manipulated against resistance during use, the device may kink and subsequently fracture.Based on the reported event, the root cause of resistance during the procedure could not be determined.Further evaluation revealed kinks along the catheter shaft.This damage is incidental to the reported complaint and may have occurred during snaring for removal or handling post 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 coil embolization procedure in the anterior communicating artery (acomm) using a benchmark 6f 071 delivery catheter (benchmark), a sheath, coils, a flow diverter, and a guidewire.During the procedure, the physician positioned the benchmark in the petrous segment of the internal carotid artery (ica).Upon removal at the end of the procedure, it was noted that the benchmark was fractured and the proximal third was retrieved.The physician then gained access in the opposite femoral artery and used a snare device to retrieve the fractured segment of the benchmark.The procedure ended at this point.There was no report of an adverse effect on 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: 21646803
• Report Number: 3005168196-2025-00086
• Device Sequence Number: 20756828
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: BMK6F95M
• Device Lot Number: F00013735
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: 70 YR
• Patient Sex: Male