BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1811897 · Received August 24, 2010

    Report

    Report Number
    3005099803-2010-03616
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE DISTAL STENTS LOOPS DEPLOYED. FURTHER EXAMINATION FOUND A KINK IN THE DELIVERY SYSTEM. DURING A FUNCTIONAL ANALYSIS OF THE DEVICE, AN INITIAL RESISTANCE WAS FELT WHEN THE DEPLOYMENT SUTURE WAS PULLED AND THE DELIVERY SYSTEM BOWED; THE STENT, HOWEVER, COULD STILL BE DEPLOYED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE WITHIN THE RIGHT MAIN BRONCHIAL STEM ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ONCE THE STENT HAD BEEN POSITIONED WITHIN THE STEM, THE PHYSICIAN BEGAN TO PULL ON THE DEPLOYMENT SUTURE. AFTER APPROXIMATELY HALF OF THE STENT HAD BEEN DEPLOYED, THE SUTURE GOT STUCK; THE REMAINDER OF THE STENT COULD NOT BE DEPLOYED. THE COMPLAINANT NOTED THAT THE SUTURE STRING DID NOT BREAK, AND THAT THERE WAS NO BOWING OF THE DELIVERY SYSTEM. THE STENT WAS EASILY REMOVED FROM THE PATIENT, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE WITHIN THE RIGHT MAIN BRONCHIAL STEM ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ONCE THE STENT HAD BEEN POSITIONED WITHIN THE STEM, THE PHYSICIAN BEGAN TO PULL ON THE DEPLOYMENT SUTURE. AFTER APPROXIMATELY HALF OF THE STENT HAD BEEN DEPLOYED, THE SUTURE GOT STUCK; THE REMAINDER OF THE STENT COULD NOT BE DEPLOYED. THE COMPLAINANT NOTED THAT THE SUTURE STRING DID NOT BREAK, AND THAT THERE WAS NO BOWING OF THE DELIVERY SYSTEM. THE STENT WAS EASILY REMOVED FROM THE PATIENT, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 M00564500 13130328

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR OLYMPUS BRONCHOSCOPE