BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1941820 · Received December 30, 2010

    Report

    Report Number
    3005099803-2010-05366
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    * NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05364 ADDRESSES THE FIRST ULTRAFLEX STENT THAT WAS USED, MANUFACTURER REPORT # 3005099803-2010-05365 ADDRESSES THE SECOND ULTRAFLEX STENT THAT WAS USED, AND MANUFACTURER REPORT # 3005099803-2010-05366 ADDRESSES THE THIRD STENT THAT WAS USED. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE USED DURING A BRONCHOSCOPY PROCEDURE WITHIN THE RIGHT LOBE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE STRICTURE; THE PHYSICIAN ADDED THAT THE DELIVERY SYSTEM KINKED DURING HIS ATTEMPTS TO CROSS THE STRICTURE (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05364). THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND USED THE SECOND ULTRAFLEX STENT WHEN THE SAME ISSUE OCCURRED (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05365). THE PHYSICIAN DECIDED TO THEN DILATE THE STRICTURE TO 10MM. A THIRD ULTRAFLEX STENT WAS THEN USED WHEN AGAIN THE SAME ISSUE OCCURRED (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05366). THE PHYSICIAN REMOVED THIS DEVICE AND ULTIMATELY COMPLETED THE PROCEDURE BY USING A FOURTH ULTRAFLEX TRACHEOBRONCHIAL STENT. THE PHYSICIAN ADDED THAT THE ANATOMY WAS TORTUOUS. 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 FINE.

    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 M00564770 13681277

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR