BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 1152129 · Received August 18, 2008

    Report

    Report Number
    1152129
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    June 25, 2008
    Report Date
    August 18, 2008
    Manufacturer
    EV3 INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE LAST ATTEMPT TO CROSS THE LESION WITH THE ECHELON CATHETER, THE DISTAL TIP BECAME FIRMLY LODGED IN THE LESION AND SEPARATED FROM THE REST OF THE CATHETER DURING THE CATHETER'S REMOVAL. THREE BARE METAL STENTS WERE DEPLOYED IN THE RCA TO TRAP THE RETAINED TIP UP AGAINST THE ARTERIAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATHETER CATHETER KRA EV3 INC. ECHELON -14 5664421

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES| NO OTHER THERAPIES