BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 24718852 · Received March 30, 2026

    Report

    Report Number
    3005099803-2026-01132
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. SECTION E: THIS EVENT WAS REPORTED BY THE SALES REPRESENTATIVE. THE HEALTH CARE FACILITY IS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT, WHEN TURNING THE LEVER, THE BAND DID NOT DEPLOY AND INSTEAD CAUSED IT TO SPIN IDLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37403 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0037475125 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown