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

Catalog Number BMK6F95MBER120

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 332974633
• Report Number: 3005168196-2024-00013
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815948025202
• UDI-Public: 815948025202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/12/2024

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
• Device Operator: Health Professional
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female