BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAXUS

    MDR report key: 1842614 · Received September 25, 2010

    Report

    Report Number
    MW5017501
    Event Type
    Other
    Date Received
    September 25, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 25, 2010
    Manufacturer
    UPN
    Product Code
    NIQ
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN STENT WAS UNABLE TO CROSS MID RCA LESION, STENT WAS REMOVED, BUT GOT DISLODGED FROM BALLOON BEFORE ENTERING THE GUIDE. ENTIRE SYSTEM WAS THEN PULLED OUT OF THE SHEATH. IT WAS NOTED THE STENT WAS NOT ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS STENT NIQ UPN 12883828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other