BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1965108 · Received January 20, 2011

    Report

    Report Number
    3005099803-2011-00091
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    November 4, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT PARTIALLY DEPLOYED BY ABOUT 10MM. WHEN THE DEPLOYMENT SUTURE WAS PULLED, THE STENT DEPLOYED WITHOUT ISSUE. NO PROBLEMS OR ANOMALIES WERE NOTED WITH THE STENT'S PROFILE. THE MOST PROBABLE ROOT CAUSE OF THE ISSUE HAS BEEN LABELED AS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. 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 COVERED TRACHEOBRONCHIAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LEFT MAIN BRONCHUS ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, ONCE THE DELIVERY SYSTEM WAS IN PLACE, THE PHYSICIAN COULD NOT DEPLOY THE STENT; WHEN THE DEPLOYMENT SUTURE WAS PULLED, THE DELIVERY SYSTEM BOWED. THE COMPLAINANT REPORTED THAT THERE WAS SOME MINOR BLEEDING; HOWEVER, THE BLEEDING WAS STOPPED BY ASPIRATING THE SITE WITH THE SCOPE- NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PHYSICIAN USED ANOTHER ULTRAFLEX STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY 30 MINUTES.THE PHYSICIAN NOTED THAT THE ANATOMY WAS NOT TORTUOUS, AND THAT THE STRICTURE WAS PREDILATED.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.THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS- THE STENT WAS RETURNED PARTIALLY DEPLOYED.

    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 M00564790 0013303317

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR