BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1040416 · Received May 7, 2008

    Report

    Report Number
    3005099803-2008-00437
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED ONE ADDITIONAL COMPLAINT REPORTED FOR THE LOT (SEE ASSOCIATED MANUFACTURER REPORT #3005099803-2008-00438). THE 2008 15-MONTH BAND LIGATION PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO ADVERSE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO MALFUNCTIONS THAT OCCURRED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPER VIEW SUPER 7 LIGATOR DEVICE WAS USED TO TREAT AN ESOPHAGEAL VARIX IN 2008. ACCORDING TO THE COMPLAINANT, AFTER DEPLOYING THE BANDS, THE PHYSICIAN FELT LIKE THE BANDS WERE "LOOSE". ADDITIONAL INFORMATION REVEALED THAT THE PHYSICIAN OPINED THAT THE BANDS WERE LOOSE SINCE THE COLOR OF THE VARIX DIDN'T LOOK "CHOKED OFF LIKE IT USUALLY DOES." THE PHYSICIAN NOTED THAT THE BAND FELL OFF THE VARIX. A SECOND SPEEDBAND SUPERVIEW SUPER 7 LIGATOR DEVICE WAS USED TO CONTINUE THE PROCEDURE. REFER TO MFR REPORT #3005099803-2008-00438 FOR DETAILS REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 0011202925

    Patients

    Seq Age Sex Outcome Treatment
    1