BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST TALON SEMI-FLEX

    MDR report key: 2426260 · Received January 17, 2012

    Report

    Report Number
    1056436-2012-00006
    Event Type
    Other
    Date Received
    January 17, 2012
    Date of Event
    November 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE APPEARED TO FUNCTION PROPERLY AT TIME OF SURGERY ((B)(6) 2011) 2.9 CM TUMOR INFERIOR LEFT KIDNEY RF ABLATION WITH 3CM AND 4CM DEPLOYMENT TINE CLOSEST TO URETER (2CM) AT 3CM DEPLOYMENT (1.6) AT 4CM DEPLOYMENT. PROXIMAL LEFT URETERAL THERMAL INJURY WITH URINE LEAK *DESPITE >1CM SAFETY MARGIN OF DEVICE FROM THE URETER PT REQUIRED PERCUTANEOUS DRAINAGE, URETER STENT PLACEMENT, REPEAT HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST TALON SEMI-FLEX RFA PROBE GEI ANGIODYNAMICS NA 551686

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other