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 Code	Foreign Body In Patient (2687)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a distal fracture and revealed stretching proximal to the fractured location.If the device is retracted against resistance, damage such as stretching, and subsequent fracture may occur.The reported small radial artery may have contributed to resistance experienced during the procedure.The distal fractured segment was not returned for evaluation.Further evaluation revealed ovalization and kink on the benchmark catheter shaft.This damage was incidental to the complaint and likely occurred during packaging of the device for return to penumbra.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 middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra short sheath (6f), and a guidewire.During the procedure, a short sheath was placed in the radial artery and medication was administered.While advancing the benchmark, the physician experienced resistance.An angiogram was performed and revealed that the radial artery was very small.The physician attempted to advance the benchmark further without success.Therefore, the physician decided to remove the benchmark from the patient.It was reported that the benchmark was stuck in the vessel.While attempting to remove the benchmark, the distal third of the benchmark fractured.The patient was taken to the operating room and a surgical cut down was performed to remove the distal fractured segment of the benchmark.The procedure was completed via femoral access.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20523709
• Report Number: 3005168196-2024-00356
• Device Sequence Number: 8119057
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 00815948025189
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024
• Report Date (Section F): 01/01/2005

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: F00013042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005