BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 2955675 · Received February 11, 2013

    Report

    Report Number
    3005099803-2013-00752
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) STENT POSITIONING ISSUE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM WAS USED DURING A BRONCHOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR LUNG CANCER. THE LESION WAS LOCATED IN THE RIGHT UPPER LOBE OF THE BRONCHUS. THE PATIENT WAS NOT NOTED TO HAVE TORTUOUS ANATOMY. DURING THE PROCEDURE, AS THE STENT WAS BEING DEPLOYED, THE DEPLOYMENT SUTURE WAS "CATCHING". AS A RESULT, THE CATHETER KINKED AND THE STENT WAS NOT RELEASED IN THE DESIRED LOCATION. THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59299 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00576410 15162920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention