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

Model Number	BMK6F95BER120
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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 using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the proximal end of a benchmark kinked and fractured; therefore, it was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked and fractured approximately 2.0 cm from the hub.The benchmark was ovalized approximately 94.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed that the catheter was kinked and fractured underneath the strain relief.If the benchmark is forcefully manipulated at an extreme angle or otherwise mishandle during use, damage such as a kink and subsequently fracture may occur.Further evaluation of the returned benchmark revealed ovalization in the distal shaft.This damage was likely incidental to the reported complaint.Penumbra catheters are visually 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
• MDR Report Key: 10916650
• Report Number: 3005168196-2020-02123
• Device Sequence Number: 2644558
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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 Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/29/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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