BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC SCI-MED INC

    MDR report key: 414168 · Received September 4, 2002

    Report

    Report Number
    414168
    Event Type
    Injury
    Date Received
    September 4, 2002
    Date of Event
    June 10, 2002
    Report Date
    July 11, 2002
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE TIP BROKE OFF IN CORONARY ARTERY AND UNABLE TO REMOVE. REMAINED IN THE DISTAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC SCI-MED INC GUIDE WIRE DQX BOSTON SCIENTIFIC 300CM MOD SUPPORT 4359050

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention