BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1171396 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04634
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON AUGUST 18, 2008 THAT A FLEXIMA BILIARY STENT SYSTEM DEVICE WAS USED IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE STENT WAS PLACED IN THE BILE DUCT WITHOUT RESISTANCE". "UPON CATHETER AND WIRE RETRACTION FOR STENT RELEASE, THE SUTURE WAS CAUGHT IN THE FLAP AND FAILED TO RELEASE." THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORPORATION M00539210 9697490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK