BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 2972078 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-01117
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    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

    (B)(4) FOR THE REPORTED ISSUE OF STENT COVER MISSING. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE COMPLAINANT PROVIDED AN IMAGE OF THE DEVICE POST DEPLOYMENT. A REVIEW OF THE IMAGE BY BSC COULD NOT DEFINITIVELY CONCLUDE IF THE COVER WAS MISSING, AS THE COVER IS TRANSLUCENT AND DIFFICULT TO VISUALIZE ONCE WET. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS IMPLANTED WITHIN THE RIGHT BRONCHUS OF A PATIENT ON (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STENOSIS CAUSED BY A TUMOR WITHIN THE RIGHT BRONCHUS. THE PATIENT'S ANATOMY WAS REPORTED TO NOT BE TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO STENT PLACEMENT. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE RIGHT BRONCHUS. HOWEVER, FOLLOWING DEPLOYMENT, IT WAS NOTICED THAT THE STENT COVER WAS MISSING. NO INTERVENTION WAS PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77173 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564750 15648535

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR