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

Model Number	BMK6F105BER130
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A 5-french bernstein diagnostic catheter within a 6-french benchmark guide catheter was advanced freely up the right arm into the right subclavian artery under native fluoroscopic guidance.When advancing the diagnostic and guide catheters, there was resistance encountered in the mid-upper arm.The diagnostic catheter was removed and selective angiography through the guide catheter was performed demonstrating inadvertent selection of a small artery arising from the right brachial artery.2mg of intra-arterial verapamil was infused through the guide catheter to help facilitate removal of the catheter and alleviate any vasospasm.After administration of verapamil, an attempt was made to withdraw the guide catheter; however, the guide catheter broke leaving a retained fragment in the right arm.It appeared as if the catheter had fractured and then unraveled, leaving a small inner coil fragment from the catheter itself tethered from the upper arm to the arterial access site at the right wrist.Manufacturer response for catheter, percutaneous, benchmark (per site reporter): they will investigate.

• Brand Name: BENCHMARK
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12804983
• Report Number: 12804983
• Device Sequence Number: 4756947
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: (01)00814548014029(17)240513(10)F106264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/03/2021
• Report Date (Section F): 11/03/2021

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: BMK6F105BER130
• Device Lot Number: F106264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2021
• 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: Female
• Patient Weight: 88 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 11/03/2021