BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

    MDR report key: 2021811 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00875
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2011-00876 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BLEEDING VARICES, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, FOR THE FIRST DEVICE, DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THEY FOUND THAT THE SUTURE ON THE LIGATOR HEAD WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE PACKAGE. FOR THE SECOND DEVICE, IT WAS REPORTED THAT WHEN THEY DEPLOYED THE BANDS ONTO THE TARGET SITE, THE BANDS FELL OFF THE VARICES. THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR