BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XL, 9 ARRAY, 3-5CM, 15CM

    MDR report key: 1051766 · Received May 21, 2008

    Report

    Report Number
    1056436-2008-00022
    Event Type
    Other
    Date Received
    May 21, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "AFTER REGIONAL ANESTHESIA OF LIDOCAINE, ONE OF THE DOCTOR OF INTERVENTION DEPT BEGAN RFA UNDER CT SCAN. THE 2.5CM HCC WAS UNDER THE HEPATIC SUBCAPSULAR WHEN THE TEMP WENT ON MORE THAN 60, THE PT SHOW TRISMUS, CYANOSIS AND CONVULSION. BUT THE PT'S BLOOD PRESSURE AND PULSE IS NORMAL DURING THIS TIME. DR TURNED RF OFF FOR A MINUTE AND PUT RF ON WITH THE TARGET POWER TO 80W AND TARGET TEMPERATURE TO 90. WHEN THE TEMPERATURE WENT ON MORE THAN 60, THE PT SHOW TRISMUS, CYANOSIS AND CONVULSION AGAIN. DR THOUGHT THE TUMOR WAS UNDER THE HEPATIC SUBCAPSULAR AND A LOT OF NERVOUS WERE UNDER THE HEPATIC SUBCAPSULAR TOO. THE HEAT CONDUCTION MAYBE CAUSE NERVOUS REFLEX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XL, 9 ARRAY, 3-5CM, 15CM ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS, INC. NA 945037

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other