BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY BALLOON DILATATION CATHETER

    MDR report key: 1080625 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02034
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K993305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WITHDRAWAL DIFFICULTY WAS ENCOUNTERED. THE LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6F INTRODUCER SHEATH WAS USED TO GAIN ACCESS TO THE LESION. IT WAS NOTED THAT RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR OPERATION, AND THERE WAS NOT A SIGNIFICANT BEND IN THE LESION. THE LESION WAS APPROXIMATELY 80-85% STENOTIC. THE SYNERGY BALLOON WAS INFLATED TWICE TO 12 ATMS USING AN ENCORE INFLATION DEVICE, WITH NO ISSUES NOTED. THE INFLATION DEVICE WAS THEN EXCHANGED FOR A 20 CC SYRINGE, AND THE USER PULLED NEGATIVE IN AN ATTEMPT TO DEFLATE THE BALLOON. THE USER ENCOUNTERED DIFFICULTY DEFLATING THE BALLOON, AND UPON WITHDRAWAL, NOTED THAT THE BALLOON CATHETER COULD NOT BE REMOVED THROUGH THE SHEATH. THEREFORE, THE SHEATH AND THE BALLOON CATHETER WERE REMOVED AS A UNIT. FOLLOWING REMOVAL FROM THE BODY, IT WAS NOTED THAT THE BALLOON DETACHED FROM THE SHAFT AND ONE OF THE RADIOPAQUE MARKERS WAS "FLOATING." NOTHING REMAINED IN THE PATIENT. IT WAS NOTED THAT EITHER THE BALLOON WAS NOT COMPLETELY DEFLATED WHEN THE USER ATTEMPTED TO WITHDRAW THE CATHETER THROUGH THE SHEATH, OR DURING WITHDRAWAL THROUGH THE SHEATH DAMAGE OCCURRED TO THE SHAFT THAT DEFORMED THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 11734135

    Patients

    Seq Age Sex Outcome Treatment
    1