BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

    MDR report key: 2173501 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02448
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE EXACT EVENT DATE IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE EVENT TOOK PLACE APPROXIMATELY TWO WEEKS PRIOR TO (B)(6), 2011. 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 FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAS A HISTORY OF ALCOHOLISM AND PREVIOUS REPEATED ESOPHAGEAL VARICES BANDING PROCEDURES. THE PHYSICIAN HAD PREVIOUSLY RECOMMENDED A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC STENT SHUNT) PROCEDURE, BUT THE PATIENT DECLINED. DURING THIS PROCEDURE, THE PHYSICIAN MADE TWO ATTEMPTS TO DEPLOY A BAND, BUT THE BAND FAILED TO DEPLOY. WHEN THE DEVICE WAS REMOVED, THE PHYSICIAN OBSERVED THAT THE BANDS WERE OVERLAPPING EACH OTHER. DUE TO THE HEAVY BLEEDING, THE PATIENT WAS ADMITTED TO THE ICU AND UNDERWENT THE TIPS PROCEDURE. THE SPEEDBAND DEVICE DID NOT CAUSE OR EXACERBATE THE PATIENT BLEED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 14330568

    Patients

    Seq Age Sex Outcome Treatment
    1