MAUDE Adverse Event Report: TERUMO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that immediately following the implant of a transcatheter bioprosthetic valve, a terumo guide catheter that was being used for pre-planned, simultaneous percutaneous coronary intervention (pci) became caught on the valve frame causing the valve to be inclined.A snare was used to pull the valve up and a second valve was successfully implanted valve-in-valve.The patient's native valve leaflets were reported to be heavily calcified.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO
• MDR Report Key: 17526335
• MDR Text Key: 321434960
• Report Number: MW5133274
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1