BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? TRACHEOBRONCHIAL

    MDR report key: 3800245 · Received May 8, 2014

    Report

    Report Number
    3005099803-2014-01879
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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 PROXIMAL END OF THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 30MM. IT WAS ALSO NOTED THAT THE SHAFT WAS BENT PROXIMAL TO THE STENT. DURING ANALYSIS IT WAS POSSIBLE TO RETRACT THE DEPLOYMENT SUTURE AND FULLY DEPLOY THE STENT WITHOUT A RESTRICTION; HOWEVER THE SHAFT DID BOW DURING DEPLOYMENT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. 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.  THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.  A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS BEING USED TO TREAT A LESION IN THE BRONCHIAL TUBES VIA AN ENDOTRACHEAL TUBE DURING A PROCEDURE PERFORMED ON (B)(6) 2014. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE DEPLOYMENT SUTURE TANGLED AND COULD NOT BE FULLY RELEASED. THE PARTIALLY DEPLOYED STENT AND THE ENDOTRACHEAL TUBE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS BEING USED TO TREAT A LESION IN THE BRONCHIAL TUBES VIA AN ENDOTRACHEAL TUBE DURING A PROCEDURE PERFORMED ON (B)(6) 2014. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE DEPLOYMENT SUTURE TANGLED AND COULD NOT BE FULLY RELEASED. THE PARTIALLY DEPLOYED STENT AND THE ENDOTRACHEAL TUBE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277815 ULTRAFLEX? TRACHEOBRONCHIAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00564670 16469281

    Patients

    Seq Age Sex Outcome Treatment
    1