BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 2903502 · Received January 6, 2013

    Report

    Report Number
    2903502
    Event Type
    Malfunction
    Date Received
    January 6, 2013
    Date of Event
    September 13, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING CYSTO-URETEROSOPY PROCEDURE, SURGEON USING BOSTON SCIENTIFIC SENSOR DUEL FLEX STRAIGHT-TIP WIRE NOTED DEBRIS (POSSIBLE COATING?) BEGAN FLAKING OFF DEVICE AND FLOATING IN THE STERILE IRRIGATION FLUID. WIRE REMOVED AND NEW REPLACEMENT DEVICE GIVEN TO SURGEON. PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5997 SENSOR WIRE, GUIDE, CATHETER EZB BOSTON SCIENTIFIC CORPORATION * 15388343

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR