BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22180712 · Received June 10, 2025

    Report

    Report Number
    3005099803-2025-02664
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    EXEMPT
    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. A2 AGE AT TIME OF EVENT: PATIENT IS NOT UNDER 18 YEARS OF AGE. D2B PRODUCT CODE: 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 DURING AN ENDOSCOPIC ESOPHAGEAL VARICEAL LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE THE RUBBER BAND WAS DISCOVERED TO BE TANGLED AND FAILED TO DEPLOY. PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103003 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0035320745 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown