MAUDE Adverse Event Report: PENUMBRA INC PENUMBRA JET 7 KIT - REPERFUSION CATHETER 132 CM + PENUBRA HI-FLOW ASPIRATION TU; CATHETER, THROMBUS RETRIEVER

Model Number 5MAXJET7BKIT

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

Catheter malfunction and fracture all pieces of catheter retrieved and retained.Fda safety report id # (b)(4).

• Brand Name: PENUMBRA JET 7 KIT - REPERFUSION CATHETER 132 CM + PENUBRA HI-FLOW ASPIRATION TU
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA INC; 1321 harbor bay parkway; CA 94502
• MDR Report Key: 11170087
• MDR Text Key: 227099849
• Report Number: MW5098817
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5MAXJET7BKIT
• Device Lot Number: C23986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Weight: 90