BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1181725 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04932
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED BILARY PROCEDURE, RESISTANCE AND ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. UPON ATTEMPTING TO ADVANCE THE 7 X 10CM RX STENT DELIVERY SYSTEM (SDS) OVER AN UNSPECIFIED GUIDE WIRE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THROUGH THE CHANNEL OF AN UNSPECIFIED ENDOSCOPE. IT WAS NOTED BY THE PHYSICIAN THAT THE INNER CATHETER OF THE SDS HAD COME OUT THROUGH THE GUIDE WIRE PORT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545570 11656237

    Patients

    Seq Age Sex Outcome Treatment
    1