BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX STENT SYSTEM

    MDR report key: 835893 · Received April 5, 2007

    Report

    Report Number
    6000050-2007-00036
    Event Type
    Injury
    Date Received
    April 5, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    JCT
    PMA / PMN Number
    k963241
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELEATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THE PERTINENT LOT. THE FEBRUARY 2007, 15-MONTHS TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON MARCH 13, 2007 THAT AFTER THE PLACEMENT OF AN ULTRAFLEX STENT SYSTEM (PT AGE AND GENDER UNK), THE STENT WOULD NOT EXPAND. THE PHYSICIAN "TRIED TO OPEN THE STENT WITH THE ENDOSCOPE" AND WAS NOT SUCCESSFUL. HE REMOVED THE DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY USING ANOTHER SAME DEVICE. THE PT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX STENT SYSTEM JCT JCT BOSTON SCIENTIFIC CORP. M00569510 9192878

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention