BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTCA CATHETER

    MDR report key: 494949 · Received November 12, 2003

    Report

    Report Number
    6000093-2003-00347
    Event Type
    Injury
    Date Received
    November 12, 2003
    Date of Event
    September 27, 2003
    Report Date
    October 15, 2003
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED PTA TREATMENT PROCEDURE, THE MAVERICK MONORAIL BALLOON CATHETER BROKE. IN 2003, THE PT UNDERWENT ANGIOGRAPHY FOR EVALUATION OF PERIPHERAL VASCULAR DISEASE. THE PT WAS FOUND TO HAVE SEVERE, EXTENSIVE PERIPHERAL VASCULAR DISEASE IN BOTH LOWER EXTREMITIES AND OCCLUSION OF A PREVIOUSLY PLACED GRAFT ON THE LEFT. A CATHETER WAS PLACED IN THE BYPASS GRAFT AND A THROMBOLYTIC INFUSION AND A HEPARIN DRIP WERE INSTITUTED. THE FOLLOWING DAY, THE PT WAS TAKEN FOR EVALUATION OF THE OVERNIGHT TREATMENT. THE GRAFT WAS FREE OF THROMBUS, HOWEVER, THERE WAS NO FLOW THROUGH THE GRAFT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A GUIDE WIRE AND THE MAVERICK MONORAIL BALLOON CATHETER INTO THE DISTAL PORTION OF THE GRAFT, WITH THE INTENT OF CROSSING THE OBSTRUCTION TO PRODUCE BLOOD FLOW INTO THE DISTAL VESSELS. THE PHYSICIAN WAS UNABLE TO CROSS THE OBSTRUCTION/HIGH GRADE STENOSIS. AT THIS POINT, IT WAS DETERMINED THAT FURTHER ENDOVASCULAR TREATMENT WOULD NOT BE AN OPTION. WHILE REMOVING THE GUIDE WIRE AND THE BALLOON CATHETER, THE CATHETER BROKE IN THE VESSEL AND EXTENDED FROM THE RIGHT GROIN OVER THE BIFURCATION AND DISTALLY A CONSIDERABLE DISTANCE INTO THE GRAFT. UNSUCCESSFUL ATTEMPTS WERE MADE TO PULL THE CATHETER FRAGMENT OUT WITH THE SHEATH. THE PT WAS TAKEN TO THE O.R. FOR REMOVAL OF THE CATHETER FRAGMENT AND EMBOLECTOMY THROUGH AN ARTERIOTOMY. DUE TO THE SEVERITY OF THE BILATERAL DISEASE AND THE POOR PROGNOSIS FOR BYPASS SURGERY, THE PT ELECTED TO UNDERGO BILATERAL ABOVE THE KNEE AMPUTATIONS 3 DAYS LATER. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA CATHETER MAVERICK MONORAIL PTCA CATHETER LOX BOSTON SCIENTIFIC MAV-MR 9/2.0 3705216

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R