MAUDE Adverse Event Report: PENUMBRA INC. PENUMBRIA; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	LITNG7XTORQ130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Penumbra catheter broke in vivo and was removed by physician in entirety.Fda safety report id # (b)(4).

• Brand Name: PENUMBRIA
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): PENUMBRA INC.
• MDR Report Key: 12633531
• Report Number: MW5104610
• Device Sequence Number: 11078756
• Product Code: QEW
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: LITNG7XTORQ130
• Device Lot Number: F104729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1