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

Model Number	BMK6F105BER130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a fracture near the hub.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.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.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.During the procedure, the hospital fellow flexed the benchmark at the proximal end/ hub while advancing it through the sheath.Consequently, the benchmark broke just after the hub.Therefore, the benchmark was removed.The procedure was completed by using a new benchmark and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11662650
• Report Number: 3005168196-2021-00748
• Device Sequence Number: 11517134
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Report Date (Section B): 03/17/2021
• 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: 07/10/2023
• Device Model Number: BMK6F105BER130
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F98800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• 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: 03/17/2021
• Initial Report FDA Received Date: 04/14/2021
• 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