BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1181097 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04930
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    July 11, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE PULL WIRE WAS BENT. A 7 X 10CM RX BILIARY STENT HAD BEEN SELECTED TO TREAT AN UNSPECIFIED TARGET LESION. WHILE LOADING THE DEVICE ONTO AN UNSPECIFIED GUIDE WIRE, THE PULL WIRE BECAME BENT AND CAME OUT OF THE DEVICE WITH THE GUIDE WIRE AT THE "OPENING OF INTRODUCER CATHETER". THE DEVICE DID NOT COME INTO CONTACT WITH THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATION REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545570 11242510

    Patients

    Seq Age Sex Outcome Treatment
    1