BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPPEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1023645 · Received April 1, 2008

    Report

    Report Number
    3005099803-2008-00317
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 29, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE MFR DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION IS NOT AVAILABLE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED; THEREFORE, THE CUSTOMER'S SHIPMENT HISTORY WAS REVIEWED TO IDENTIFY A POTENTIAL LOT NUMBER FOR THE SUSPECT DEVICE. THE SEARCH IDENTIFIED THREE POTENTIAL LOTS. THE DEVICE HISTORY FOR EACH LOT WAS REVIEWED; NO ISSUES WERE NOTED. 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 DEVICE WAS USED TO TREAT ESOPHAGEAL VARICES (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO FIRE ONE BAND AND IT DID NOT DEPLOY; A SECOND ATTEMPT RESULTED IN THE DEPLOYMENT OF MULTIPLE BANDS. AS A RESULT, THE BANDS THAT MISFIRED WERE LEFT "INSIDE THE PT TO PASS NATURALLY." THE PROCEDURE WAS COMPLETED WITH A SECOND SPEEDBAND SUPER VIEW 7 LIGATOR DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPPEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK