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

Model Number	BMK6F105BER130
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 102.5 and 103.5 cm from the hub.The neuron select catheter 5f (5f select) was undamaged.Conclusions: evaluation of the returned benchmark confirmed kinks on the distal shaft.If the device is forcefully advanced against resistance, damage such as kinks may occur.It was reported that the benchmark was advanced into the patient without a delivery catheter.This may have contributed to resistance while advancing during the procedure.During functional testing, the returned 5f select was advanced through the benchmark without an issue.The benchmark was then advanced through a demonstration neuron max without an issue.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 to treat an arteriovenous malformation (avm) using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, while advancing the benchmark over the guidewire with no delivery catheter in the carotid artery, the benchmark kinked; therefore, it was removed.It was reported that the physician experienced resistance while removing the benchmark.The procedure was completed using another benchmark.There was no report of an adverse effect to the patient.

• 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: 10228388
• Report Number: 3005168196-2020-00883
• Device Sequence Number: 18981082
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 06/08/2020
• 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: 11/04/2022
• Device Model Number: BMK6F105BER130
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F94052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• 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: 06/08/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005