BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE INTERVENTION WIRE

    MDR report key: 2171909 · Received September 13, 2006

    Report

    Report Number
    2171909
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    August 4, 2006
    Report Date
    September 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION ON THE CIRCUMFLEX ARTERY, WIRE INSERTED AND PASSED INTO CIRCUMFLEX ARTERY. WHEN AN EFFORT WAS MADE TO PASS THE LESION, APPROX 2.5 CM OF THE WIRE TIP FRACTURED OFF AND WAS FLOATING IN THE ARTERY. ATTEMPTS TO SNARE THE WIRE WERE UNSUCCESSFUL TO OPERATING ROOM FOR CABG X 1 AND RETRIEVED. MANUFACTURER'S REP NOTIFIED ON DAY OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE INTERVENTION WIRE ANGIOPLASTY WIRE DQX BOSTON SCIENTIFIC CORP. 12130-01 8780496

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR