BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2450189 · Received February 8, 2012

    Report

    Report Number
    MW5024204
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 8, 2012
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PLACING THE STENT WAS UNABLE TO CROSS THE LESION WITH THE STENT. THE STENT CAME OFF THE BALLOON WHEN HE ATTEMPTED TO WITHDRAWAL IT. THE STENT WAS LEFT IN THE MID RIGHT CORONARY ARTERY, ENTRAPPED, AND THE PT RECEIVED A BALLOON ANGIOPLASTY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC RX PROMUS STENT NIQ 1009544-12 1030241

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR