BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPSON CORONARY ATHEROCATH

    MDR report key: 22073 · Received May 30, 1995

    Report

    Report Number
    MW1006105
    Event Type
    Malfunction
    Date Received
    May 30, 1995
    Date of Event
    March 27, 1995
    Report Date
    May 10, 1995
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST WAS ATTEMPTING DCA TO SVC TO FIRST DIAGONAL OF LAD WHICH HAD SHARP ANGLE WITH AORTIC ANASTOMOSIS. 9.5 FR GUIDING CATHETER WAS UTILIZED. AFTER CROSSING LESION WITH DIFFICULTY WITH 7 FR ATHERECTOMY CATHETER FIRST CUT WAS MADE AT 15 PSI PEAK PRESSURE. DR STATED DID NOT HAVE GOOD CONTROL OF THE DEVICE WITH THAT CUT. AFTER INFLATING TO 15 PSI FOR 2ND CUT, WAS UNABLE TO ADVANCE CUTTER. BROKEN CABLE WAS FOUND IN SPLINE ADAPTER OF ATHERECTOMY CATHETER. DEVICE WAS REMOVED FROM PT. PROCEDURE WAS COMPLETED WITH PTCA BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPSON CORONARY ATHEROCATH ATHERECTOMY CATHETER MCX DEVICES FOR VASCULAR INTERVENTION 150441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR