BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST XLI ENHNACED SEM-FLEX, 25CM, FLEXIBL

    MDR report key: 2720515 · Received August 28, 2012

    Report

    Report Number
    1056436-2012-00075
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED A SKIN BURN AT THE SITE WHERE THE PROBE WAS INSERTED INTO THE RIGHT LATERAL SIDE. APPROXIMATELY THE SIZE OF A DIME. XLIE SEMI FLEX WAS USED FOR THE ABLATION OF A 4.7 CM TUMOR. PROTOCOL TO ACHIEVE A 7 CM ABLATION WAS FOLLOWED PER THE PRODUCT IFU INSERT. TEMP FOR THE TYNE 1 AND 6 REGISTERED "HI" WHEN XLIE WAS SET TO 6 CM. IMPEDANCE DROPPED TO 3 AND THEN 1. GENERATOR BEGAN PROCESS OF RE-HEATING TO 105 C. AFTER THE COMPLETION OF THE CASE, THE IR TECHNICIAN NOTICED THAT ONE OF THE LORAL LOCKS ON THE TUBING WAS OFF AND NOTICED THAT BLOOD WAS VISIBLE IN THE TUBING FROM THE PROBE BACK TO THE PUMP. (IMAGES TO FOLLOW). DURING THE SETUP THE PURGING OF THE XLIE PROBE, ALL TUBING WAS CONFIRMED AS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLI ENHNACED SEM-FLEX, 25CM, FLEXIBL RFA PROBE GEI ANGIODYNAMICS NA 574020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other