BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22048829 · Received May 19, 2025

    Report

    Report Number
    3005099803-2025-02245
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY. D2B: ADDITIONAL PRODUCT CODE FHN. E3: NON-HEALTHCARE PROFESSIONAL: PURCHASING ASSISTANT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS OPENED AND INSERTED INTO THE EQUIPMENT BY TRAINED PERSONNEL ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. THE DOCTOR ATTEMPTS TO RELEASE THE BANDS ON THE PATIENT, AND THE BAND BURSTS, NECESSITATING THE USE OF ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142166 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0035268305 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown