BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPSON CORONARY ATHEROCATH, 7 FR.

    MDR report key: 24083 · Received August 4, 1995

    Report

    Report Number
    MW1006613
    Event Type
    Malfunction
    Date Received
    August 4, 1995
    Date of Event
    July 12, 1995
    Report Date
    July 21, 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

    WHILE DOING DCA OF SAPHENOUS VEIN GRAFT TO LEFT ANTERIOR DESCENDING, CUTTER OF CATHETER WOULD NOT ADVANCE AND COULD NOT MANIPULATE GUIDE WIRE WITHIN DEVICE. SEVERAL CUTS HAD BEEN MADE PRIOR TO DEVICE NOT FUNCTIONING. CATHETER AND GUIDE WIRE REMOVED FROM PT WITHOUT INCIDENT AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPSON CORONARY ATHEROCATH, 7 FR. 7 FR EX ATHEROCATH MCX DEVICES FOR VASCULAR INTERVENTION 142911

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR