BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

    MDR report key: 1833747 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03916
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 BAND LIGATION DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT BLEEDING VARICES. ACCORDING TO THE COMPLAINANT, THE DEVICE BANDS DIDN'T COME OFF OF THE LIGATOR HEAD, AS EXPECTED. NORMALLY, THE BANDS WOULD RELEASE AT THE SAME TIME THE HANDLE "CLICKS", BUT THE HANDLE DIDN'T MAKE THAT NOISE. A COUPLE OF THE BANDS DEPLOYED FINE, THEN TWO BANDS CAME OFF AT THE SAME TIME, AND FINALLY ONE BAND DIDN'T DEPLOY. THEY STOPPED USING THIS DEVICE AT THAT TIME. THIS EVENT DID NOT EXACERBATE THE BLEEDING, AND THE BLEEDING HAD STOPPED AT THE END OF THE PROCEDURE. THE PATIENT WAS SENT TO THE HOSPITAL FOR OBSERVATION ONLY, AS HE HAD A PREVIOUS HISTORY OF BLEEDING VARICES. THE PATIENT IS FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR