BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIB

    MDR report key: 1692856 · Received May 17, 2010

    Report

    Report Number
    1056436-2010-00036
    Event Type
    Other
    Date Received
    May 17, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 17, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NO INJURY. PT IS FINE. RFA OF THE LIVER. THEY WERE PLANNING TO DO A 5-6CM ABLATION. EXTENDED TINES OUT TO 5CM THEN SCAN. AFTER SCAN, RETRACT TINES BACK TO 2CM TO START ABLATION. WHEN RETRACTING BACK THEY FELT SOMETHING WAS NOT RIGHT. TOOK ANOTHER SCAN. THEY WERE ABLE TO TELL A TINE HAD BUSTED OFF. THEY ENDED UP DOING THE ABLATION. WHEN FINISHED IT WAS CONFIRMED THAT A TINE WAS BUSTED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIB RFA PROBE GEI ANGIODYNAMICS NA 507764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other