BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 2223106 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02847
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 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 DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY CROCHETED ONTO THE SHAFT OF THE DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE STENT. THE DEPLOYMENT THREAD HAD COME AWAY FROM THE DISTAL SILASTIC TUBING. IN ADDITION, THE SHAFT HAD BEEN STRETCHED AND WAS BUCKLED BETWEEN THE PROXIMAL END OF THE STENT AND THE SIDEPORT. THE LENGTH OF THE DEVICE FROM THE DISTAL TIP TO THE SIDEPORT WAS MEASURED AND FOUND TO BE LONGER THAN SPECIFICATION. THE YELLOW PULLRING WAS POSITIONING WITHIN THE HUB. NO OTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE. THE DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE PERFORMANCE OF THE DEVICE WAS LIMITED LIKELY DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A TRACHEA STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE TRACHEA AS A RESULT OF LUNG CANCER. THE STRICTURE WAS LOCATED WITHIN THE DISTAL TRACHEA NEAR THE MAIN BRONCHIA AND WAS APPROXIMATELY 4CM IN LENGTH. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE PATIENT AT THE LOCATION OF THE STRICTURE. HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ADVANCING THE STENT SYSTEM ACROSS THE LESION. THE STENT SYSTEM WAS WITHDRAWN FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE STENT CATHETER APPEARED STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A TRACHEA STENTING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE TRACHEA AS A RESULT OF LUNG CANCER. THE STRICTURE WAS LOCATED WITHIN THE DISTAL TRACHEA NEAR THE MAIN BRONCHIA AND WAS APPROXIMATELY 4CM IN LENGTH. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE PATIENT AT THE LOCATION OF THE STRICTURE. HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ADVANCING THE STENT SYSTEM ACROSS THE LESION. THE STENT SYSTEM WAS WITHDRAWN FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE STENT CATHETER APPEARED STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564810 14088047

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR