BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1203349 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05270
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. A BILIARY STENT 10FR/5CM HAD BEEN ADVANCED TO THE DUCTUS CHOLEDOCHUS. THE STENT WAS UNABLE TO BE DEPLOYED AS THE SUTURE WAS "ALWAYS AROUND THE STENT". THE STENT WAS REMOVED WITH THE REMOVAL OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS ABORTED AND WILL BE ATTEMPTED AGAIN IN 2 WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539300 11900244

    Patients

    Seq Age Sex Outcome Treatment
    1