BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1032075 · Received April 9, 2008

    Report

    Report Number
    3005099803-2008-00338
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE FEB 2008 15-MONTH ULTRAFLEX ESOPHAGEAL STENT PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, HAS BEEN REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT 3005099803-2008-00337. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT TWO ULTRAFLEX COVERED NG ESOPHAGEAL STENTS WERE PLACED IN A MALE PT (WEIGHT UNK) APPROX 7 MONTHS AGO. ACCORDING TO THE COMPLAINANT, IN 2007, "THE PT WAS ADMITTED WITH DYSPHAGIA. [THE PHYSICIAN PERFORMED AN] EGD (ESOPHAGOGASTRODUODENOSCOPY) AND FOUND PIECES OF A RUBBERY LIKE SUBSTANCE CLOGGING [THE] LOWER ESOPHAGUS. [THE] SUBSTANCE [WAS] REMOVED [AND] SENT TO PATHOLOGY. [THE] SUBSTANCE APPEAR [ED] TO BE THE COVERING FROM [ONE OF] THE STENT [S]." THE PHYSICIAN VERIFIED "THE REMAINDER OF THE COVERING WAS INTACT; HOWEVER, IT WAS BLACK." AT THE CONCLUSION OF THE PROCEDURE, THE "PT [WAS SENT] HOME AND WAS ABLE TO PASS FOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW ESW BOSTON SCIENTIFIC IRELAND, LTD M00513750 0009671994

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention