BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS

    MDR report key: 1210423 · Received October 10, 2008

    Report

    Report Number
    1210423
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 21, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    DURING PCI, COULD NOT CROSS LESION WITH BALLOON CATHETER STENT LOADED ON CATHETER. UPON TAKING CATHETER OUT, ENTERING GUIDING CATHETER STENT SLIPPED OFF BALLOON, LOST IN PT. PT TAKEN TO THE OR EMERGENTLY AND CABG X 1. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC * 8010241

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR