BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT

    MDR report key: 1193261 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05082
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    JCT
    PMA / PMN Number
    K963241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND 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 UNSPECIFIED STENTING PROCEDURE, A PARTIAL DEPLOYMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED TRACHEOBRONCHIAL PASSAGE. THE 2.5CM ULTRAFLEX TRACHEOBRONCHIAL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, HOWEVER, UPON DEPLOYMENT, A "SUTURE BLOCKAGE" OCCURRED AND ONLY THE DISTAL END OF THE STENT WAS ABLE TO BE DEPLOYED. THE PHYSICIAN ATTEMPTED TO RELEASE THE SUTURE KNOTS, BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT JCT- PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC M00569480 11521975

    Patients

    Seq Age Sex Outcome Treatment
    1