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

Catalog Number	BMK6F95MBER120
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra coils.It was reported that the patient¿s anatomy has vertebral artery stenosis.During the procedure, the physician placed one coil in the target location.While advancing another coil through the benchmark, the physician noticed the benchmark was kinked at the proximal end.It was reported there was a leak where the kink had occurred.Therefore, the benchmark was removed and was not used for the remainder of the procedure.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the device was kinked near its proximal end underneath the strain relief, and a hole was present at the kinked location.The presence of a hole at the kinked location indicates that the benchmark was fractured at that point.If the benchmark is handled at an angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an additional kink on the proximal shaft and multiple ovalizations along the length of the device.This damage was incidental to the complaint and may have occurred during packaging for the device return.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.

• 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: 18469812
• Report Number: 3005168196-2024-00013
• Device Sequence Number: 11542063
• Product Code: DQY
• UDI-Device Identifier: 00815948025202
• UDI-Public: 815948025202
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F00008732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: 77 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005