BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM

    MDR report key: 1080633 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02048
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOTIC LESION WAS LOCATED IN THE MODERATELY CALCIFIED RENAL ARTERY. THE LESION WAS NOT PREDILATED, AND THERE WAS NO RESISTANCE ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT DELIVERY SYSTEM (SDS). THE SDS WAS ADVANCED TO THE LESION, AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING INFLATION AT 6 ATMS. THEREFORE, THE SDS WAS REMOVED, AND THE STENT REMAINED IN THE VESSEL. THE STENT DID NOT MIGRATE AFTER THE BALLOON RUPTURE. A STERLING BALLOON CATHETER WAS THEN ADVANCED TO THE LESION, AND THE STENT WAS POST-DILATED SUCCESSFULLY. THE PHYSICIAN FEELS THAT THE PATIENT IS ADEQUATELY PROTECTED, AND THE STENT IS FULLY OPPOSED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 9341393

    Patients

    Seq Age Sex Outcome Treatment
    1