BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1693460 · Received May 13, 2010

    Report

    Report Number
    MW5015976
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, SURGEON USING BOSTON SCIENTIFIC 5FR ANGLED TIP URETERAL CATHETER WITH GUIDE WIRE REF NO. 400-251. THE INNER LUMEN OF THE CATHETER APPEARED TO HAVE PEELED OFF AND WAS LODGED IN THE PT'S URETER. CATHETER REMNANT HAD TO BE RETRIEVED TO PREVENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ANGLED TIP URETERAL CATHETER W GUIDEWIRE 5FR X 70 CM EYB BOSTON SCIENTIFIC 13290555

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Disability