BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2935568 · Received January 30, 2013

    Report

    Report Number
    3005099803-2013-00203
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT CAME TO THE EMERGENCY ROOM AND PRESENTED WITH BLEEDING. WHILE IN THE ER, DUE TO THE BLEED, THE PATIENT NEEDED TO BE RESUSCITATED. WHILE BEING RESUSCITATED IN THE ER, THE PATIENT WAS EXPOSED TO LATEX AND AS A RESULT BROKE OUT IN HIVES DUE TO AN ALLERGIC REACTION WITH THE MATERIAL. ONCE STABLE, THE PATIENT WAS BROUGHT IN TO HAVE THE BANDING PROCEDURE TO RESOLVE THE BLEEDING. REPORTEDLY, THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE WAS USED AS A RESULT OF BEING LATEX FREE. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY SIX BANDS ONTO THE VARIX; HOWEVER, THE SEVENTH BAND MISFIRED, RELEASING OFF TO THE SIDE AND MISSING THE VARIX. AS THE SCOPE WAS WITHDRAWN FROM THE PATIENT, ALL SIX BANDS DETACHED FROM THE VARIX AND WERE LEFT IN THE PATIENT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41507 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542250

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR