BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC KINETIX

    MDR report key: 1980041 · Received January 31, 2011

    Report

    Report Number
    MW5019246
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISTAL 2 INCHES OF KINETIC WERE SNAPPED OFF THE WIRE AT THE TAKEOFF OF A SMALL RV BRANCH. THE RCA STENT STRUTS PROBABLY CUT THE WIRE AT THE OSTIUM OF THE VESSEL. THE WIRE DOES NOT PROTRUDE IN THE MAIN RCA TRUNK. NO EXPECTED CONSEQUENCES FROM SUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC KINETIX PTCA GUIDEWIRE, 0.014IN X 185CM DQX BOSTON SCIENTIFIC CORP CE0086 13827196

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR