BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND

    MDR report key: 1022185 · Received March 26, 2008

    Report

    Report Number
    3005099803-2008-00301
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION IS NOT AVAILABLE. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD OF THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED ONE ADDITIONAL COMPLAINT FOR THIS LOT; FOR AN UNRELATED ISSUE (BAND DISPLACEMENT). THE FEBRUARY 2007 15-MONTH BAND LIGATION PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A SPEEDBAND SUPER VIEW SUPER 7 LIGATOR WAS USED TO TREAT ESOPHAGEAL VARICES IN AN ADULT FEMALE PATIENT IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE "THE FIRST THREE BANDS DEPLOYED PROPERLY" AND THE PHYSICIAN ATTEMPTED THE FOURTH BAND, WHICH WAS NOT SUCCESSFUL. THE FIFTH BAND WAS ATTEMPTED AND "TWO BANDS DEPLOYED OVER THE VARIX" AT THE SAME TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPER VIEW SUPER 7 LIGATOR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND MND BOSTON SCIENTIFIC CORPORATION M00542253 11013699

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK