BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1133481 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03825
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    April 16, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, THE ANALYSIS IS NOT COMPLETE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE JULY 2008, 15-MONTH WALLFLEX ENTERAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED IN A DUODENAL STENTING PROCEDURE ABOUT THREE MONTHS PRIOR. ACCORDING TO THE COMPLAINANT, "THEY WENT OVER THE GUIDEWIRE IN THE RIGHT POSITION, AND WANTED TO DEPLOY THE STENT, BUT DURING THAT, THE OUTER SHEET TORE OFF FROM THE RELEASE UNIT. THEY PULLED OFF THE SYSTEM, AND FINISHED THE PROCEDURE WITH ANOTHER "WALLFLEX ENTERAL DUODENAL STENT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT WAS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MQR BOSTON SCIENTIFIC CORPORATION M00565020 11590693

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN