BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22737353 · Received August 7, 2025

    Report

    Report Number
    3005099803-2025-03782
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    May 9, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    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 D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. SECTION E: THIS EVENT WAS REPORTED BY THE OTHER BSC EMPLOYEE. THE HEALTHCARE FACILITY IS: (B)(6). BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED.

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. SECTION E: THIS EVENT WAS REPORTED BY THE OTHER BSC EMPLOYEE. THE HEALTHCARE FACILITY IS: BOSTON SCIENTIFIC DO BRASIL LTDA AV NACOES UNIDAS 21476, ED P8/9/10, SAO PAULO, SP, BRAZIL 04794-900. PHONE: (B)(6). EMAIL: (B)(6). BLOCK H6: IMDRF DEVICE CODE A22 CAPTURES THE REPORTABLE EVENT OF BANDS FELL OFF THE VARIX.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE SECOND TO THE LAST BAND WAS RELEASED, IT CAME LOOSE. THE SAME PROBLEM OCCURRED WITH THE LAST BAND. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE SECOND TO THE LAST BAND WAS RELEASED, IT CAME LOOSE. THE SAME PROBLEM OCCURRED WITH THE LAST BAND. 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
    940312 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown