BEUDAMED
    FDA Adverse Event Summary report: N

    PT GRAPHIX JTIP INTERMEDIATE 182 CM "J" GW

    MDR report key: 1215983 · Received October 16, 2008

    Report

    Report Number
    1215983
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    DURING PTCA, PHYSICIAN WAS ATTEMPTING TO ADVANCE A PT GRAPHIX J-TIP WIRE INTO THE CIRCUMFLEX ARTERY, A SECOND PT GRAPHIX STRAIGHT WIRE WAS ALSO INTRODUCED INTO THE CIRCUMFLEX FOR EXTRA SUPPORT. POST DILATION, THE PHYSICIAN PULLED THE BALLOON AND BOTH WIRES OUT. IT WAS THEN DISCOVERED THAT THE TIP OF THE PT GRAPHIX WIRE WAS RETAINED IN THE PROXIMAL LAD. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE WIRE TIP. A DECISION WAS MADE TO LEAVE THE TIP, DUE TO ITS DISTAL LOCATION. A CLOSURE DEVICE WAS THEN UTILIZED AND ANGIOSEAL WAS PERFORMED. PATIENT UNDERWENT ADDITIONAL ANGIOGRAPHY TO ENSURE STABILITY AND WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX JTIP INTERMEDIATE 182 CM "J" GW GUIDEWIRE DQX BOSTON SCIENTIFIC * 11743433

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR