BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 2220162 · Received August 16, 2011

    Report

    Report Number
    1319211-2011-00072
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH.

    Description of Event or Problem · 1

    A PT OF UNK GENDER AND AGE PRESENTED FOR AN EVLT PROCEDURE. IT WAS REPORTED BY THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE THAT THE 0.035" GUIDEWIRE SHREDDED IN THE PT'S LEG. THE DEVICE WAS SUCCESSFULLY REMOVED W/O INCIDENT. THERE WAS NO HARM OR INJURY REPORTED TO THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 539743

    Patients

    Seq Age Sex Outcome Treatment
    1