BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUGAR XT STEERABLE GUIDEWIRE

    MDR report key: 2024210 · Received March 3, 2011

    Report

    Report Number
    2024210
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TAKEN TO THE ELECTROPHYSIOLOGY LAB FOR PLACEMENT OF AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WITH LEADS. INTRAPROCEDURE, THE PHYSICIAN WAS ABLE TO GET A ST. JUDE LEAD OVER A MEDTRONIC COUGAR XT GUIDEWIRE, BUT WHILE TRYING TO RETRACT THE WIRE, IT BECAME STUCK WITHIN THE LEAD AND UNRAVELED. THE WIRE AND LEAD WERE REMOVED. PHYSICIAN WENT IN A SECOND TIME WITH ANOTHER LEAD AND USED A WHISPER GUIDE WIRE. THE LEAD WAS POSITIONED, BUT IN TRYING TO RETRACT THE GUIDE WIRE, THE DISTAL 5CM OF THE WHISPER WIRE SHEARED OFF AND STAYED IN THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGAR XT STEERABLE GUIDEWIRE MEDTRONIC COUGAR XT STEERABLE GUIDEWIRE DQX MEDTRONIC * GB128
    2 HI TORQUE WHISPER MS GUIDE WIRE HI TORQUE WHISPER MS GUIDE WIRE DQX ABBOTT VASCULAR * 0111201

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR NO OTHER THERAPIES