BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 951890 · Received November 21, 2007

    Report

    Report Number
    6000050-2007-00151
    Event Type
    Malfunction
    Date Received
    November 21, 2007
    Date of Event
    October 26, 2007
    Report Date
    October 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINT REPORTED FOR THE SAME LOT. THE OCTOBER 2001 15-MONTH WALLFLEX ENTERAL STENT PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED AND NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A WALLFLEX ENTERAL COLONIC STENT WAS USED IN A STENT PLACEMENT PROCEDURE ON A MALE PT (WEIGHT UNK) IN 2007. ACCORDING TO THE COMPLAINANT, "... THE STENT ONLY DEPLOYED HALFWAY. UPON TRYING TO CONTINUE TO DEPLOY THE STENT, THE CATHETER BROKE. WHEN THE CATHETER BROKE, THEY PULLED THE CATHETER OUT OF THE PT, ALONG WITH THE HALFWAY DEPLOYED STENT. THEY USED ANOTHER WALLFLEX TO COMPLETE THE CASE WITH NO COMPLICATIONS." REPORTEDLY, THE PT WAS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR BOSTON SCIENTIFIC IRELAND, LTD. M00565050 9411547

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR