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

Catalog Number	BMK6F105
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
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 right internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra coils, a non-penumbra microcatheter and a non-penumbra micro-guide catheter.During the procedure, the physician successfully implanted the coils in the target vessel.While performing a series of contrast runs, the physician noticed that only a small amount of the contrast came out the benchmark and the imaging was a little less cloudy than usual.The physician suspected a leak and decided to remove the benchmark.Subsequently, while retracting the benchmark, the distal end of the benchmark fractured and unraveled in the brachial artery.Therefore, a vascular surgeon performed a surgical cut down to retrieve the fractured distal end of the benchmark from the brachial artery.It was also reported that the benchmark might have been damaged at the beginning of the procedure.The procedure ended 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 catheter was fractured near the distal end.This damage typically occurs due to retraction against resistance.Based on the reported complaint, it is unknown if resistance was experienced.Further evaluation revealed multiple kinks along the catheter shaft and on the distal tip.Stretching was also found on the distal fractured segment.The kinks on the distal tip may have contributed to the small amount of contrast coming out of the benchmark during the procedure and maybe the reported damage at the beginning of the procedure.Several of these kinks were likely incidental and may have occurred post-procedure.Evaluation also revealed a cut on the distal tip.The cut likely occurred during surgical cut down to retrieve the distal fractured segment and was incidental to the complaint.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
• 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: 16773196
• Report Number: 3005168196-2023-00176
• Device Sequence Number: 6378116
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 814548014012
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2023
• 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: 10/24/2025
• Device Catalogue Number: BMK6F105
• Device Lot Number: F00003740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005