BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR

    MDR report key: 1519551 · Received October 30, 2009

    Report

    Report Number
    3005099803-2009-05136
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    October 3, 2009
    Report Date
    October 5, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP, THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH ESOPHAGEAL BANDING, PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, THE PT WAS IN THE ICU IN VERY CRITICAL CONDITION WITH PROFUSE BLEEDING FROM ESOPHAGEAL VARICES. DURING THE PROCEDURE, WHILE USING THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR, FOUR BANDS WERE PLACED. THREE OF THE BANDS FELL OFF THE VARICES, AND BLEEDING CONTINUED. THE PHYSICIAN INJECTED ETHAMOLIN, PLUS CLIPPED THE HOLE WITH TWO CLIPS, WHICH CONTROLLED THE BLEEDING. ONCE BLEEDING WAS CONTROLLED, THE PT'S STATUS REMAINED CRITICAL. TRANSFUSIONS CONTINUED AND PLATELETS WERE ADMINISTERED. AT LAST REPORT, THE PT REMAINS IN THE HOSPITAL, BUT THEIR CONDITION IS NOW REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 12754477

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention