BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 2900417 · Received January 7, 2013

    Report

    Report Number
    3005099803-2012-06372
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (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 DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED BY 32 MM. DURING A FUNCTIONAL ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINDER OF THE DEPLOYMENT SUTURE THREAD AND DEPLOY THE STENT WITHOUT ANY ISSUE. IT WAS NOTED THAT THE SHAFT OF THE DEVICE WAS KINKED AT 64 MM AND 109 MM PROXIMAL TO THE DISTAL TIP. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 CONFIRMED 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 INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. 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 COVERED STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE LEFT MAIN STEM BRONCHUS OF A PATIENT ON (B)(6) 2012 DURING A BRONCHOSCOPY PROCEDURE WITH STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE WITHIN THE LEFT MAIN STEM BRONCHUS. DURING THE PROCEDURE, DIFFICULTIES WERE ENCOUNTERED IN DEPLOYING THE STENT. IT WAS REPORTED THAT THE STENT BUCKLED DURING DEPLOYMENT AND ONLY 1 CM OF THE STENT WAS ABLE TO BE RELEASED. SUBSEQUENTLY, THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND A SHORTER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS REPORTED TO BE LONGER AND SEDATION WAS REPEATED. HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE LEFT MAIN STEM BRONCHUS OF A PATIENT ON (B)(6) 2012 DURING A BRONCHOSCOPY PROCEDURE WITH STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE WITHIN THE LEFT MAIN STEM BRONCHUS. DURING THE PROCEDURE, DIFFICULTIES WERE ENCOUNTERED IN DEPLOYING THE STENT. IT WAS REPORTED THAT THE STENT BUCKLED DURING DEPLOYMENT AND ONLY 1 CM OF THE STENT WAS ABLE TO BE RELEASED. SUBSEQUENTLY, THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND A SHORTER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS REPORTED TO BE LONGER AND SEDATION WAS REPEATED. HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6913 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564780 0015551057

    Patients

    Seq Age Sex Outcome Treatment
    1