BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22189713 · Received June 11, 2025

    Report

    Report Number
    3005099803-2025-02714
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    April 6, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO, IMDRF CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED/RESCHEDULED - POST SEDATION / SEDATION UNKNOWN. D2B: ADDITIONAL PRODUCT CODE FHN.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO IMDRF CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED/RESCHEDULED - POST SEDATION / SEDATION UNKNOWN. D2B: ADDITIONAL PRODUCT CODE FHN. CORRECTION: B3: DATE OF EVENT. B5: DESCRIBE EVENT OR PROBLEM. G4: PREMARKET / 510(K) #. ADDITIONAL INFORMATION: A1: PATIENT IDENTIFIER. A2: AGE AT TIME OF EVENT; UNIT OF MEASURE (AGE). A3: SEX; GENDER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE UNKNOWN ANATOMICAL LOCATION DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR STATED THAT THE BANDS JAMMED AND COULD NOT RELEASE ANY MORE BANDS AFTER THE 3RD ONE. PROCEDURE WAS CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS FOR TREATMENT OF ERADICATION OF ESOPHAGEAL VARICES DURING AN UPPER DIGESTIVE ENDOSCOPY ON (B)(6) 2025. DURING THE PROCEDURE, THREE SUCCESSFUL LIGATIONS WERE COMPLETED. ON THE FOURTH ATTEMPT, DESPITE ASPIRATION AND ROTATION OF THE HANDLE, THE ELASTIC BAND WAS NOT RELEASED. A SECOND ATTEMPT AT RELEASE WAS ALSO UNSUCCESSFUL. THE GASTROSCOPE WAS WITHDRAWN FROM THE ESOPHAGUS, AND THE HANDLE WAS OBSERVED TO SPIN FREELY WITHOUT RELEASING THE SUBSEQUENT BANDS. PROCEDURE WAS CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94797 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0034495415 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male