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

Model Number	BMK6F95MBER120
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing an embolization procedure in the middle meningeal artery (mma) using a benchmark delivery catheter (benchmark), a non-penumbra catheter and a non-penumbra sheath.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician experienced resistance advancing the non-penumbra catheter into the benchmark.Therefore, the physician decided to withdraw the catheter; however, the catheter became stuck inside the benchmark.When the physician pulled on the non-penumbra catheter, the benchmark broke at the distal end.Subsequently, the distal part of the benchmark migrated to the iliac artery.The benchmark and the non-penumbra catheter were removed from the patient.Then, through a second access point at the opposite side in the groin, a snare device and a balloon were introduced, and the broken part of the benchmark was successfully retrieved.The procedure was completed using a new benchmark, a new catheter, and a new sheath through the second access point.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.Evaluation also revealed that the device was stretched near the fracture location.This damage typically occurs due to forceful retraction of the benchmark against resistance.Based on the reported event, resistance was experienced manipulating the non-penumbra select catheter inside the benchmark.This may have contributed to the damage observed on the benchmark catheter.The distal fractured benchmark segment was damaged throughout its length.This damage was likely incidental to the reported complaint and may have occurred during snaring and removal from the patient.Penumbra products 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 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: 13419573
• Report Number: 3005168196-2022-00035
• Device Sequence Number: 5047698
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/08/2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F109147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005