BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22473429 · Received July 10, 2025

    Report

    Report Number
    3005099803-2025-03181
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1:(B)(6). BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DUE TO A RUPTURE OF ESOPHAGEAL AND GASTRIC FUNDUS VARICES DURING A VARICOSE VEIN LIGATION PROCEDURE PERFORMED ON JUNE 4, 2025, FOR THE TREATMENT OF ESOPHAGEAL VARICES AND ANORECTAL HEMORRHOIDS. DURING THE PROCEDURE, AFTER THE LIGATOR WAS INSTALLED NORMALLY, IT COULD NOT BE DEPLOYED PROPERLY STARTING FROM THE LIGATION OF THE FIRST BAND. THIS CAUSED A PAUSE IN THE PROCEDURE, INCREASING THE RISKS OF BLEEDING AND SUBSEQUENT INFECTION. THE PROCEDURE WAS DELAYED FOR TEN MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE BANDS WERE OVERLAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119540 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0035709921 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male