BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 21985868 · Received May 8, 2025

    Report

    Report Number
    3005099803-2025-02085
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY. D2B: ADDITIONAL PRODUCT CODE FHN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS FOR AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SPEEDBAND SUPERVIEW SUPER 7 BAND CANNOT BE FIRED SMOOTHLY. PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997991 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0033899271 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown