BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGM CABLE

    MDR report key: 1068509 · Received July 2, 2008

    Report

    Report Number
    2953184-2008-00022
    Event Type
    Injury
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    DSA
    PMA / PMN Number
    P990054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY BEING EVALUATED. FOLLOW-UP REPORTS WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC IN 2008 THAT WHILE USING A CHILLI II CATHETER, THE CUSTOMER EXPERIENCED THE FOLLOWING: DURING AN ATRIAL FLUTTER ABLATION CASE, THE TEMPERATURE READING FROM THE CHILLI CATHETER DID NOT CHANGE WHEN THE POWER WAS INCREASED. THE IMPEDANCE WAS HIGH, AROUND 200 OHMS, AND HAD NO REDUCTION IN INTRACARDIAL SIGNAL. CHANGING THE CABLE HAD NO EFFECT. AFTER 20 ABLATIONS, THE DOCTOR REPLACED THE CHILLI CATHETER WITH A J&J THERMOCOOL CATHETER AND MADE 20 MORE ABLATIONS. THE IMPEDANCE REMAINED HIGH WITH NO CHANGE. THE PROCEDURE WAS STOPPED WITHOUT SUCCESS. THREE HOURS AFTER THE PROCEDURE, TWO CIRCULAR SKIN BURNS (3CM DIAMETER) WERE FOUND ON ONE OF THE PATIENT'S LEGS (1ST OR 2ND DEGREE). THE DOCTOR BELIEVES THAT DURING THE ABLATION, THE POWER DID NOT GO OUT OF THE PATIENT THROUGH THE GROUND PAD, AND THE BURNED AREA OCCURRED BECAUSE THE CHILLI CATHETER AND/OR ONE OF THE CABLES WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGM CABLE DSA. CABLE, TRANSDUCER & ELECTRODE, PT. DSA BOSTON SCIENTIFIC, EP TECHNOLOGIES 2062 8534361

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other BSC TTT (MFG REPORT #2953184-2008-00024)| BSC CABLES (MFG REPORT #2953184-2008-00023)| BSC CHILLI II CATHETER (MFG #2953184-2008-00025)| STOCKERT GENERATOR| J AND J THERMOCOOL CATHETER| BSC STOCKERT CABLE| GROUND PAD (NOT SUPPLIED BY BSC)