BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1051666 · Received May 19, 2008

    Report

    Report Number
    3005099803-2008-00506
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K0329300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE TO EXPAND, OUTER SHEATH PERFORATION - THE DEVICE REMAINS IMPLANTED IN THE PATIENT. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORT MALFUNCTION IS UNDETERMINED. A SEARCH OF THE DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 21, 2008, THAT A ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE. ON TWELVE DAYS EARLIER. ACCORDING TO THE COMPLAINANT, "AFTER DEPLOYMENT OF THE STENT IN THE ESOPHAGUS, THE STENT DID NOT EXPAND. IN ADDITION, THE STENT WIRES WERE PROTRUDING THE OUTER SHEATH OF THE STENT. THE PHYSICIAN PLACED ANOTHER ULTRAFLEX COVERED NG ESOPHAGEAL STENT INSIDE THE FIRST ONE." NO COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD. M00513730 11563401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK