BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR DUAL-FLEX PTFE-NOTINOL GW W/HYDRO TIP

    MDR report key: 684862 · Received March 9, 2006

    Report

    Report Number
    6000111-2006-00003
    Event Type
    Injury
    Date Received
    March 9, 2006
    Date of Event
    November 29, 2005
    Report Date
    January 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FLEXIBLE TIP OF THIS GUIDEWIRE BROKE INTO TWO PIECES IN THE PATIENT'S BLADDER DURING A THERAPEUTIC URETEROSCOPY PROCEDURE. THE DETACHED SEGMENTS WERE SUCCESSFULLY RETRIEVED AND THERE WERE NO PATIENT COMPLICATIONS INVOLVED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR DUAL-FLEX PTFE-NOTINOL GW W/HYDRO TIP UROLOGICAL GUIDEWIRE EZB BOSTON SCIENTIFIC NA 8157229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other