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

Model Number	BMK6F95MBER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar artery using a benchmark 6f 071 delivery catheter (benchmark), a penumbra system 3max reperfusion catheter (3maxc), and a non-penumbra catheter.During the procedure, the physician placed the benchmark in the v3 segment of the left vertebral artery using radial access.While the physician attempted to advance the catheter through the benchmark, the physician experienced resistance; and the catheter would not advance through.Therefore, the physician removed the catheter.Subsequently, the physician attempted to advance three other catheters through the benchmark; however, the same issue occurred.Therefore, the three catheters were also removed.Afterwards, while advancing a 3maxc through the benchmark, the physician experienced resistance.However, the physician was able to advance the 3maxc through the benchmark and completed the procedure with one pass using the 3maxc and benchmark.Upon removal of the benchmark and the 3maxc, the physician noticed that the distal end of the benchmark was broken.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed the device was kinked on its distal shaft.This kink was likely the reported distal damage.Based on the reported event, the root cause of this damage could not be determined.This damage likely contributed to the reported resistance during advancement of catheters through the benchmark.If the benchmark is manipulated against resistance, damage such as a kink may occur.Penumbra products 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to a serious injury or death.

• Brand Name: BENCHMARK 6F 071 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: 13674452
• Report Number: 3005168196-2022-00101
• Device Sequence Number: 4893874
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022
• 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: 08/15/2024
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F108404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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