BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND MULTIPLE BAND LIGATOR

    MDR report key: 857444 · Received May 30, 2007

    Report

    Report Number
    6000048-2007-00186
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MND
    PMA / PMN Number
    K990864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS- NO CONCLUSION CAN BE DRAWN. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER; SO AN EVALUATION CANNOT BE PERFORMED, AND THEREFORE A ROOT CAUSE FOR FAILURE MODE IS NOT KNOWN AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED DUE TO THE LOT NUMBER BEING PROVIDED. A DHR REVIEW WAS CONDUCTED ON LOTS 8995301, 8987089 AND 8982446, THE LAST THREE LOTS SHIPPED TO THE CUSTOMER BEFORE THE PROCEDURE DATE. THE REVIEW REVEALED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THIS INCIDENT. A COMPLAINT REVIEW WAS ALSO CONDUCTED ON LOTS 8995301, 8987089 AND 8982446 AND FOUND NO COMPLAINTS REPORTED FROM ANY OF THE 3 LOTS. THE APRIL 2007 ROLLING 15 MONTH COMPLAINT TREND CHART WAS REVIEWED FOR THE BAND LIGATION PRODUCT FAMILY AND SHOWED THAT THE PRODUCT FAMILY DOES NOT SHOW A NEGATIVE TREND AND NEITHER IS AT NOR ABOVE A TOTAL NUMBER OF COMPLAINTS WHICH WOULD WARRANT FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A FEMALE PT (AGE UNKNOWN) UNDERWENT A HEMOSTASIS LIGATION PROCEDURE WITHIN THE ESOPHAGUS DURING WHICH THE PHYSICIAN PERFORMED BAND LIGATION WITH THE USE OF A BSC SPEEDBAND MULTIPLE BAND LIGATOR DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, "THE STRING BROKE." THE PHYSICIAN REMOVED THE DEVICE FROM THE PT AND USED ANOTHER ONE SUCCESSFULLY. IT WAS REPORTED THAT NO COMPLICATIONS WERE EXPERIENCED AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND MULTIPLE BAND LIGATOR MND BOSTON SCIENTIFIC M00542251 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR