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

Model Number	6F 071
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Penumbra benchmark delivery catheter 5f advanced and stent would not deploy, removed and casing accordion shape and unable to thread.Next catheter advanced and piece broke off.Able to retrieve.Fda safety report id# (b)(4).

• Brand Name: BENCHMARK DELIVERY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; alameda CA 94502
• MDR Report Key: 13282472
• Report Number: MW5106690
• Device Sequence Number: 4900595
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: (01)00814548014173(17)240914(10)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/12/2022
• 2 Devices were Involved in the Event: 1 2

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: 09/14/2024
• Device Model Number: 6F 071
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F109147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 29 KG