BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOPAD

    MDR report key: 3143032 · Received May 30, 2013

    Report

    Report Number
    1056436-2013-00037
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K031926
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS DEVICES THERMOPAD, TALON SEMI-FLEX, THERMOPAD CABLE AND 1500X GENERATOR ACT AS SYSTEM FOR RADIOFREQUENCY ABLATION AND ALL FOUR DEVICES WERE USED DURING THIS REPORTED EVENT. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFO WILL BE SENT VIA A FOLLOW UP MEDWATCH. DEVICE 2: BRAND NAME: STARBURST TALON SEMI-FLEX, DEVICE NAME: RADIOFREQUENCY ABLATION PROBE, CATALOG #: 700-102845; DEVICE 3: BRAND NAME: ADAPTER CABLE, THERMOPAD, DEVICE NAME: RADIOFREQUENCY ABLATION CABLE, CATALOG #: 700-102648; AND DEVICE 4: BRAND NAME: MODEL 1500X RF GENERATOR, DEVICE NAME: RADIOFREQUENCY ABLATION GENERATOR, CATALOG #: 700-101731.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013 BY THE USER FACILITY PHYSICIAN TO THE MFR'S SALES REP, "PATIENT INCURRED A PAD BURN DURING CT GUIDED ABLATION WITH THE TALON SEMI-FLEX. PER A CONVERSATION WITH THE PHYSICIAN, THEY WERE PERFORMING 4 OR 5 OVERLAPPING ABLATIONS AND DID NOT NOTICE THE THERMOPAD TEMPERATURE FEEDBACK WAS SHOWING PAD TEMPS OF OVER 42 DEGREES CELSIUS. THE PHYSICIAN STATED HE DID WISH THERE WAS AN ALARM NOTIFYING HIM OF THE HIGH TEMPS". THE PATIENT WAS RELEASED FROM THE HOSPITAL BUT RECEIVING HOME CARE DUE TO THE WOUND VAC PLACED IN THE BURNED AREA AND THE GRAFT AREA BEING CLOSELY MONITORED. A SKIN GRAFT WAS DONE TO REPAIR THE BURNED AREA. PER THE USER FACILITY THE PATIENT RECEIVED A 4TH DEGREE BURN DOWN TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239819 THERMOPAD RADIOFREQUENCY ABLATION PAD GEI ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R