BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22029329 · Received May 15, 2025

    Report

    Report Number
    3005099803-2025-02226
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. IMDRF CODE A0401 CAPTURES THE REPORTABLE EVENT OF TRIP WIRE BREAK. BLOCK D2B: ADDITIONAL PRODUCT CODE FHN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE AND ONCE THE SUPER 7 WAS ATTACHED TO THE SCOPE, THE PHYSICIAN PROCEEDED TO DEPLOY BANDS WITHIN THE ESOPHAGUS. THE PHYSICIAN DEPLOYED 4 OF THE BANDS THEN HE SAYS THAT THE 'WIRE BROKE' ON THE DEPLOYMENT SYSTEM. HE THEN REMOVED THE SCOPE AND REPLACE WITH A NEW DEVICE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011163 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0035278462 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown