BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1931641 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05196
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. SINCE THE COMPLAINT DEVICE REMAINS IMPLANTED, IT WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS IMPLANTED INTO A PATIENT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE ULTRAFLEX STENT INTO THE RIGHT BRONCHIAL TUBE. TWO DAYS LATER, THE PHYSICIAN NOTED THAT THE PROXIMAL END OF THE STENT WAS NOT FULLY EXPANDED. TO DATE, NO INTERVENTION HAS BEEN PERFORMED TO TRY AND EXPAND THE STENT, AND IT IS UNKNOWN IF ANY WILL BE DONE. 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 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00569480 13064839

    Patients

    Seq Age Sex Outcome Treatment
    1