BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHEROCATH-GTO, 7 FR

    MDR report key: 18550 · Received December 27, 1994

    Report

    Report Number
    MW1004578
    Event Type
    Malfunction
    Date Received
    December 27, 1994
    Date of Event
    November 29, 1994
    Report Date
    December 12, 1994
    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

    DURING DIRECTIONAL CORONARY ATHERECTOMY USING A .014" EXTRA SUPPORT GUIDE WIRE ACROSS CORONARY LESION. RPTR WAS UNABLE TO ADVANCE ATHERECTOMY CATHETER INTO CORONARY ARTERY. GUIDE WIRE WAS EXCHANGEED FOR ANOTHER .014" GUIDE WIRE 300 CM AND WAS STILL UNABLE TO ADVANCE CATHETER INTO CORONARY ARTERY. ATTEMPTED TO REMOVE CATHETER FROM GUIDE WIRE WHILE IN PT; WAS UNABLE TO DO SO UNTIL FORCE WAS USED. AFTER CATHETER REMOVED FROM PT, GUIDE WIRE ADVANCED FROM DISTAL TIP TO SPLINE ADAPTER WHERE IT HUNG UP AND WOULD NOT GO PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO, 7 FR ATHERECTOMY CATHETER MCX DEVICES FOR VASCULAR INTERVENTION 142514

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR