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

Model Number	BMK6F105MBER130
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The benchmark was stretched approximately 102.5 thru 106.0 cm from the hub.The benchmark was fractured approximately 106.0 cm from the hub.The distal tip of the benchmark was present.Conclusions: evaluation of the returned benchmark confirmed that the catheter was stretched and revealed a fracture.If the benchmark is forcefully manipulated against resistance during use, damage such as stretching, and a subsequent fracture may occur.The root cause of resistance could not be determined.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the traverse sinus using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra sheath, and non-penumbra stent.During the procedure, while attempting to deploy a stent through the benchmark, the physician stretched the distal tip of the benchmark.Therefore, the benchmark was removed.The procedure was completed using a neuron max 6f 088 long sheath (neuron max), the same stent and sheath.There was no report of any 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: 11136414
• Report Number: 3005168196-2021-00039
• Device Sequence Number: 700812
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• 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): 12/10/2020
• 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: 09/03/2023
• Device Model Number: BMK6F105MBER130
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F100038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• 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: 12/10/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Date Report Sent to FDA: 01/01/2005