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

Model Number	BMK6F95BER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f071 delivery catheter (benchmark).During the procedure, upon successful deployment of the flow diverter, the physician attempted to do a final angiogram through a benchmark.When the physician flushed contrast, they noticed the benchmark was broken at the hub.Therefore, the benchmark was removed.The physician performed the final angiogram through a sim catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a fracture near the hub beneath the strain relief.If the device is mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed kinks and ovalizations along the length of the device.This damage was likely incidental to the reported complaint and the cause could not be determined.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.H3 other text : placeholder.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12465234
• Report Number: 3005168196-2021-02025
• Device Sequence Number: 17088658
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021
• 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: 04/27/2024
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F105802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/17/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005