BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1813610 · Received August 25, 2010

    Report

    Report Number
    3005099803-2010-03525
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BAND SEVERED VARIX. THE COMPLAINANT INDICATED THAT THE DEVICE 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 SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL VARICES BANDING PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY PLACED A BAND ON THE VARIX, THE BAND SEVERED THE VARICES CAUSING AN ACTIVE BLEED. SCLEROTHERAPY WAS ADMINISTERED AND THE BLEEDING WAS RESOLVED. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM FOR OBSERVATION. NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS GOOD.

    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 M00542250 13168335

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R