BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 21959313 · Received May 5, 2025

    Report

    Report Number
    3005099803-2025-02002
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    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. BLOCK 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 AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BAND WAS FASTENED PROPERLY WITH THE GASTROSCOPE THEN INSERTED THE SCOPE INSIDE THE PATIENT. THE PHYSICIAN USED SUCTION TO GRASP VARICES AND THEN HE ATTEMPTED TO DEPLOY THE BANDS. INSTEAD OF DEPLOYING THE 1ST BAND, THE ALERT BAND (6TH ONE) STARTED TO COME OUT AND GOT STUCK ON THE LIGATING UNIT. HE IMMEDIATELY WITHDREW THE SCOPE AND USED A VGRIPP VARICEAL LIGATION SYSTEM BAND WHICH WAS DEPLOYED SUCCESSFULLY AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NOTE: THERE WERE NO REPORTED DIFFICULTIES UPON SETUP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819930 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0033850206 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female