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

Model Number	BMK6F95
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.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.Further evaluation revealed multiple kinks in the distal fractured segment.This damage was incidental to the reported complaint.This damage may have occurred removal from the patient or packaging for return to penumbra.Penumbra products are visually 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 an embolization procedure to treat a right internal carotid artery (ica) aneurysm using a benchmark 6f 071 delivery catheter (benchmark), neuron select catheter 5f (5f select), two non-penumbra microcatheters, a non-penumbra embolization device and a guidewire.During the procedure, the physician placed a benchmark via radial access with no issue and delivered the embolization device with the microcatheters inside the benchmark.While performing angiography, the physician noticed air entering the syringe prior to injecting the contrast into the benchmark.Therefore, the physician exchanged the benchmark with a new benchmark; however, the same issue was observed.It was reported that the two benchmarks were cracked and leaking near the hub.Then, a third benchmark was opened to continue with the procedure.While attempting to advance the microcatheters into the third benchmark, the physician experienced resistance and the microcatheters could not be advanced.Next, the physician exchanged the guidewire and when the physician pulled the benchmark from the patient's arm, the benchmark broke approximately 10 centimeters from the hub and the remaining distal section remained inside the patient.Subsequently, the procedure was completed using another device through a femoral approach.After completion of the procedure, a vascular surgeon removed the broken part of the benchmark via a cutdown technique in the arm.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• 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: 13578360
• Report Number: 3005168196-2022-00067
• Device Sequence Number: 5526689
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 00814548014111
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2022
• 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 Expiration Date: 09/07/2024
• Device Model Number: BMK6F95
• Device Catalogue Number: BMK6F95
• Device Lot Number: F108920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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: 69
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005