BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? TRACHEOBRONCHIAL

    MDR report key: 4840834 · Received June 12, 2015

    Report

    Report Number
    3005099803-2015-01639
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    February 10, 2015
    Report Date
    May 22, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K141584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ULTRAFLEX TRACHEOBRONCHIAL STENT WITH THE DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY CROCHETED ONTO THE DELIVERY CATHETER. DURING FUNCTIONAL ANALYSIS, A RESTRICTION WAS MET AND THE STENT COULD NOT BE DEPLOYED; A DOUBLE KNOT WAS FOUND AT THE POINT OF RELEASE FROM THE STENT. THE SUTURE WAS DISSECTED, PULLED THROUGH THE LAST CROCHET STITCH AND THE STENT WAS ABLE TO BE DEPLOYED WITHOUT ISSUE. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT AS THE STENT WAS MOUNTED ON THE DELIVERY SYSTEM. INVESTIGATION DETERMINED THAT DURING THE POST CROCHET PROCESS, THE SUTURE HAD BEEN INADVERTENTLY PASSED THROUGH THE LAST CROCHET STITCH. WHEN THE DEPLOYMENT SUTURE WAS PULLED DURING THE CLINICAL PROCEDURE, A KNOT FORMED WHICH PREVENTED DEPLOYMENT OF THE STENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS MANUFACTURING. AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. 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 ON (B)(4) 2015 THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHIAL STENT PLACEMENT PROCEDURE PERFORMED IN THE LEFT MAINSTEM BROCHUS ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE STENT WAS TO BE PLACED TO TREAT A 3X3CM CENTRAL AIRWAY OBSTRUCTION (CAO) DUE TO CANCER. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO THE STENT PLACEMENT. THERE WAS NO VISIBLE DAMAGE NOTED TO THE DEVICE PRIOR TO USE. DURING THE PROCEDURE, THE SUTURE DID NOT UNRAVEL AND THE STENT WAS UNABLE TO BE DEPLOYED. THE CATHETER ALSO BECAME BOWED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT BUT THE COMPLAINANT REPORTED THAT ON (B)(6) 2015 A STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE PATIENT. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT SUTURE WAS KNOTTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384710 ULTRAFLEX? TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00576550 0017593153

    Patients

    Seq Age Sex Outcome Treatment
    1