BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOPAD

    MDR report key: 1023382 · Received April 2, 2008

    Report

    Report Number
    1056436-2008-00014
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A STARBURST XL 10CM PROBE WAS USED TO ABLATE THREE AREAS OF THE PT'S METASTIC BONE TUMOR LOCATED IN THE RIGHT ACETABULUM. THE KATECHO (RED) GROUNDING PADS WERE PLACED ON THE PT'S RIGHT LEG. THE ABLATION WAS INITIATED, BUT WAS UNABLE TO ACHIEVE A SUCCESS AT 150W. THE ABLATION WAS ENDED AND THE KATECHO GROUNDING PADS WERE REPLACED BY THERMOPADS (BLUE) GROUNDING PADS. THE ABLATION WAS RESTARTED. DURING THE ABLATION, THE THERMOMETERS ON BOTH PADS REGISTERED 44 DEGREES CELSIUS, PROMPTING THE MACHINE TO AUTOMATICALLY SHUT OFF POWER DELIVERY TO PREVENT A PAD BURN. THE ABLATION WAS STILL UNSUCCESSFUL AT THIS POINT. THE PT'S DRAPE WAS LIFTED AND THE LEG PROPPED UP TO INCREASE AIR CIRCULATION AROUND THE GROUNDING PADS. ICE PACKS WERE ALSO PLACED AROUND THE GROUNDING PAD TO DECREASE THE PAD TEMP SO THAT THE ABLATION COULD BE CONTINUED. THE ABLATION WAS INITIATED AGAIN AND COMPLETED SUCCESSFULLY. ABLATIONS #2 AND #3 WERE ALSO COMPLETED SUCCESSFULLY. DURING THESE THREE ABLATIONS, THE PADS REGISTERED SAFE TEMPS BETWEEN 33 AND 40 DEGREES CELSIUS. THERE WAS NO APPARENT MALFUNCTION OF THE MACHINE OR THE GROUNDING PADS USED. AFTER THE CASE THE PADS WERE REMOVED AND REDNESS AND BLISTERING WERE OBSERVED BY THE CT STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPAD RF PAD GEI ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other