BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1193210 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02940
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED AND NON CALCIFIED LESION WAS LOCATED IN THE 45 DEGREE TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. WHILE ATTEMPTING TO ADVANCE ANOTHER MANUFACTURER'S GUIDE CATHETER OVER THE AMPLATZ SUPER STIFF GUIDE WIRE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. BOTH THE GUIDE CATHETER AND AMPLATZ SUPER STIFF GUIDE WIRE WERE REMOVED TOGETHER. IT WAS FURTHER REPORTED THAT PRIOR TO THE PROCEDURE "SMALL NOTCHES ON GUIDE WIRE THAT WERE NOT VISIBLE BUT COULD BE FELT" WERE NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 11847921

    Patients

    Seq Age Sex Outcome Treatment
    1 SPECTRANETUICS 035 90CM QUICKCROSS| 65CM KUMPE COOK