BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 6104481 · Received November 15, 2016

    Report

    Report Number
    3005099803-2016-03591
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 24, 2016
    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 EVENT OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; 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 ON (B)(6) 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE USED IN THE RIGHT BRONCHUS INTERMEDIUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN PULLED THE SUTURE TO DEPLOY THE STENT, THE DELIVERY SYSTEM BOWED AND SLIPPED OUT OF THE BRONCHUS. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754158 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564750 18465577

    Patients

    Seq Age Sex Outcome Treatment
    1