BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX? TRACHEOBRONCHIAL

    MDR report key: 3120195 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-04303
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF CATHETER(DELIVERY SYSTEM) DIFFICULT TO REMOVE/WITHDRAW. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 STENT WAS IMPLANTED DURING A BRONCHIAL STENTING PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS DILATION OF A BRONCHIAL STENOSIS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE STENT WAS UNINTENTIONALLY REMOVED WITH THE DELIVERY SYSTEM, WHEN REMOVING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER OF THE SAME SIZE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS NOT AVAILABLE, THEREFORE, THE PROCEDURE COULD NOT BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE STENT PLACEMENT PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221912 ULTRAFLEX? TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other