BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE MAX BALLOON DILATATION CATHETER

    MDR report key: 1163565 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02653
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FISTULOGRAM AND DECLOTTING PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT BRACHIAL VEIN. THE PHYSICIAN MADE AN INCISION TO EXPOSE THE GRAFT AND A TRANSVERSE INCISION WAS MADE IN THE GRAFT. THROMBECTOMY WAS PERFORMED AT THE GRAFT MAIN JUNCTION USING A #5 FOGARTY THROMBECTOMY CATHETER. THE PATIENT WAS ADMINISTERED 5000 UNITS OF HEPARIN. AN UNSPECIFIED CONTRAST MEDIA WAS INJECTED INTO THE VEIN AT WHICH TIME FLUOROSCOPIC VISUALIZATION NOTED "A LARGE STENT ON THE VEIN THAT IS 70% STENOSED AND A 90% STENOSIS IN THE AXILLARY VEIN". THE BLUE MAX 8MM X 8MM BALLOON CATHETER WAS ADVANCED FOR DILATATION OF AN UNSPECIFIED STENOSIS, HOWEVER, IT WAS NOTED THAT THE STENOSIS WAS "VERY RESISTANT TO DILATATION". THE PHYSICIAN ADVANCED AN UNSPECIFIED HIGH PRESSURE BALLOON CATHETER AND INFLATED THE BALLOON TO 26ATMS TO ACHIEVE DILATATION OF THE LESION. AN UNSPECIFIED CUTTING BALLOON WAS ADVANCED TO THE "SITE OF THE STRICTURE" AND THE BLUE MAX 8MM X 8MM BALLOON CATHETER WAS AGAIN ADVANCED AND WAS INFLATED TO 26ATMS PRESSURE AT WHICH TIME THE BALLOON RUPTURED AND DETACHED FROM THE CATHETER. AN UNSPECIFIED THROMBECTOMY CATHETER WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE BEYOND THE DETACHED BALLOON AND INFLATED. THE BALLOON WAS "DRAGGED DOWN THROUGH THE GRAFT AND WAS COMPLETELY REMOVED". CONTRAST WAS INJECTED AND FLUOROSCOPIC IMAGING REVEALED THAT "VENOUS FLOW APPEARED TO BE EXCELLENT". THE PATIENT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0009471375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ST. JUDE 8.5FR FAST INTRODUCER CATHETER