BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE - 0.014 IN X300CM

    MDR report key: 2202063 · Received August 5, 2011

    Report

    Report Number
    MW5021672
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LUGE WIRE TIP SHEARED OFF IN THE POSTERIOR CORONARY SINUS BRANCH WHILE BEING WITHDRAWN THROUGH AN INNER SELECT CATHETER. ATTEMPT TO SNARE THE TIP WAS UNSUCCESSFUL. THE WIRE TIP WAS STABLE IN POSITION THROUGHOUT THE PROCEDURE. NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE - 0.014 IN X300CM LUGE STRAIGHT TIP GUIDEWIRE WITH ICE HYDROPHILIC DQX BOSTON SCIENTIFIC CORP 13482840

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization