BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22073527 · Received May 22, 2025

    Report

    Report Number
    3005099803-2025-02272
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 14, 2025
    Report Date
    July 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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. D2B: ADDITIONAL PRODUCT CODE FHN. E3: NON-HEALTHCARE PROFESSIONAL IS QUALITY ASSURANCE COORDINATOR FOR THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY. D2B: ADDITIONAL PRODUCT CODE FHN. ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM. CORRECTION: E1: INITIAL REPORTER TITLE, FIRST NAME, LAST NAME, FACILITY NAME, ADDRESS, CITY AND PHONE . E2: HEALTH PROFESSIONAL. E3: OCCUPATION. H6: PATIENT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN AN UNKNOWN ANATOMY LOCATION DURING A BAND LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE THIRD BAND GOT STUCK INSIDE THE DRUM AND COULD NOT BE DEPLOYED, AND THE SUBSEQUENT BANDS COULD NO LONGER BE USED PROPERLY. PROCEDURE COMPLETION METHOD IS CURRENTLY UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS HAVE BEEN MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS BEEN UNABLE TO BE OBTAINED TO DATE.

    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 ESOPHAGEAL VARICES LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE THIRD BAND GOT STUCK INSIDE THE DRUM AND COULD NOT BE DEPLOYED, AND THE SUBSEQUENT BANDS COULD NO LONGER BE USED PROPERLY. THE PATIENT EXPERIENCED BLEEDING AS THE BAND WAS STUCK INSIDE THE DEVICE. THE STUCK BAND WAS REMOVED BY IRRIGATING WITH SOLUTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS HAVE BEEN MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS BEEN UNABLE TO BE OBTAINED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070715 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0035148625 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown