BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-ADAPTER/PLASTIC GUIDEWIE

    MDR report key: 55039 · Received September 18, 1996

    Report

    Report Number
    1220452-1996-00002
    Event Type
    Malfunction
    Date Received
    September 18, 1996
    Date of Event
    July 26, 1996
    Report Date
    September 18, 1996
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY PROCEDURE A PTCA BALLOON CATHETER MET SOME RESISTANCE AS IT PASSED THRU THE FULLY OPENED HEMOSTASIS VALVE OF THE DEVICE. NEXT, A STENT WAS ATTEMPTED TO BE PASSED THRU THE DEVICE WHEN CONSIDERABLE RESISTANCE WAS FELT AT THE HEMOSTASIS VALVE OF THE DEVICE DESPITE IT BEING FULLY OPENED. THE STENT HAD BECOME DISLODGED AND WAS REMOVED. IT WAS REPORTED IT WAS NECESSARY TO CHANGE THE DEVICE WHILE THE CORONARY REMAINED OCCLUDED. IT WAS REPROTED THIS DANGER WAS COMPOUNDED BY THE INABILITY TO LOOSEN THE HEMOSTASIS VALVE OF THE DEVICE WHICH WAS GRIPPING THE 0.014" GUIDE WIRE. WHILE ATTEMPTING TO REMOVE THE DEVICE, THE GUIDE WIRE CAME BACK OUT OF THE CORONARY ARTERY. AT THAT POINT THE VESSEL WAS OCCLUDED AND THERE WAS NO GUIDE WIRE IN POSITION. THE PT'S SITUATION WAS THEREFORE CRITICAL. A NEW DEVICE WAS ATTACHED, THE GUIDE WIRE RECROSSED THE OCCLUSION AND A STENT WAS DEPLOYED IN THE PROXIMAL LAD. AN EXCELLENT RESULT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-ADAPTER/PLASTIC GUIDEWIE ACCESSORY DQX MEDTRONIC INTERVENTIONAL VASCULAR, INC. AC4001P 43803

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR