BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SF

    MDR report key: 2954011 · Received January 25, 2013

    Report

    Report Number
    2954011
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO ABLATE USING THERMOCOOL SF. IMPEDENCE WAS READING 240-260, SO WE COULD NOT ABLATE. GROUNDING PADS WERE CHANGED, CABLES WHERE CHANGE AND CHECKED, AS WELL AS A NEW CATHETER, AND STILL HAD HIGH IMPEDENCE. THE ONLY WAY THAT THE CASE COULD CONTINUE WAS TO CHANGE OUT EQUIPMENT AND CATHETERS AND SWITCH TO ANOTHER PRODUCT. PRODUCTS FROM A DIFFERENT MANUFACTURER WERE USED TO COMPLETE THE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SVT ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35350 THERMOCOOL SF CATHETER, CARDIAC ABLATION OAD BIOSENSE WEBSTER BO135FJRT 15540690LA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR