BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 509582 · Received February 3, 2004

    Report

    Report Number
    509582
    Event Type
    Injury
    Date Received
    February 3, 2004
    Date of Event
    January 2, 2004
    Report Date
    January 6, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A CARDIAC CATHETERIZATION, AS THE GIDE WIRE WAS PULLED BACK FROM THE STENT PLACED IN CIRCUMFLEX AV VESSEL, THE GUIDE WIRE UNBRAIDED AND CAME APART. THE WIRE EXTENDED FROM CIRCUMFLEX VESSEL PROXIMAL THROUGH MAIN AND INTO AORTA. MULTIPLE EFFORTS WERE MADE TO SNARE THE WIRES. WIRE WAS ABLE TO BE SNARED. THE WIRE SNAPPED AGAIN. IT SEEMED TO BE CONFINED TO THE CIRCUMFLEX AND LEFT MAIN ARTERY (COROANRY). FRAGMENT OF WIRE REMAINS IN LEFT CIRCUMFLEX CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP FORTE MODERATE SUPPORT 185 CM GUIDE WIRE DQX BOSTON SCIENTIFIC CORP * 01952787

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization