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

Model Number	BMK6F95BER120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Bleeding (1888)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
6fr benchmark catheter inserted into left common carotid, end of catheter began to uncoil and cause bleed back.Catheter was removed.2nd 6fr benchmark opened and found same issue.3rd benchmark was opened without issue and used to complete procedure.Manufacturer rep notified of failure.Manufacturer response for catheter 6f benchmark 95cm str/ber, (brand not provided) (per site reporter).Failure was reported by department, replacement product sent.
Event or Problem Description
6fr benchmark catheter inserted into left common carotid, end of catheter began to uncoil and cause bleed back.Catheter was removed.2nd 6fr benchmark opened and found same issue.3rd benchmark was opened without issue and used to complete procedure.Manufacturer rep notified of failure.Manufacturer response for catheter 6f benchmark 95cm str/ber, (brand not provided) (per site reporter).Failure was reported by department, replacement product sent.

• Brand Name: BENCHMARK
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 13591113
• Report Number: 13591113
• Device Sequence Number: 10911338
• Product Code: DQY
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022
• Report Date (Section F): 01/12/2022

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
• Device Lot Number: F108075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/12/2022