BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1896856 · Received November 11, 2010

    Report

    Report Number
    3005099803-2010-04721
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND A ROOT CAUSE CANNOT BE DETERMINED. 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 ESOPHAGEAL COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, AFTER THE STENOSIS HAD BEEN PREDILATED, THE PHYSICIAN COULD NOT ADVANCE THE ULTRAFLEX STENT THROUGH THE STENOSIS. NO DAMAGE WAS NOTED TO THE STENT DELIVERY SYSTEM. BOTH A GUIDEWIRE AND SCOPE WERE USED TO TRY AND ADVANCE THE STENT THROUGH THE STENOSIS. AS A RESULT OF THIS EVENT, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND SEND THE PATIENT TO SURGERY TO UNDERGO A GASTROSTOMY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE GASTROSTOMY PROCEDURE WENT WELL, AND THE PATIENT'S CURRENT CONDITION IS LISTED AS "GOOD AND STABLE." NO ADVERSE EVENTS WERE REPORTED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513840 12843897

    Patients

    Seq Age Sex Outcome Treatment
    1