BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1032338 · Received April 22, 2008

    Report

    Report Number
    3005099803-2008-00370
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION IS NOT AVAILABLE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD OF THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    A SPEEDBAND SUPER VIEW SUPER 7 LIGATOR WAS USED TO TREAT ESOPHAGEAL VARICES ON A MALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE "(PHYSICIAN) NOTICED THE BANDS WERE FALLING OFF THE VARICES AFTER DEPLOYMENT. HE BANDED ONE AND WENT TO BAND THE OTHER AND THE FIRST ONE FELL OFF. THE DEVICE FAILED TO STOP THE BLEEDING. THE PROCEDURE WAS STOPPED AND THE PT WAS SENT TO THE ICU TO BE STABILIZED." IN THE EVENING, THE PT WAS BROUGHT BACK AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SPEEDBAND SUPER VIEW SUPER 7 LIGATOR DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "FINE". THE PHYSICIAN DID NOT BELIEVE THAT ANY COMPLICATIONS COULD RESULT FROM THE LOOSE BANDS: "WHEN THE BANDS FELL OFF THEY WENT INTO THE PT'S STOMACH. THE PT SHOULD BE ABLE TO PASS THEM WITH NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 11115824

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization