BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 2041869 · Received April 6, 2011

    Report

    Report Number
    3005099803-2011-01134
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 COVERED STENT WAS USED DURING A STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A 2CM STRICTURE WITHIN THE LEFT BRONCHUS DUE TO ESOPHAGEAL CANCER. THE ANATOMY WAS NOT TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS POSITIONED AT THE LOCATION OF THE STRICTURE. HOWEVER, AS THE PHYSICIAN PULLED THE DEPLOYMENT SUTURE TO RELEASE THE STENT, THE SUTURE BROKE WHEN THE STENT WAS PARTIALLY DEPLOYED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00569450 13177730

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR