BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 21342270 · Received February 10, 2025

    Report

    Report Number
    3005099803-2025-00377
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    December 30, 2024
    Report Date
    April 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED. BLOCK H2 (ADDITIONAL INFORMATION): BLOCK B5 AND BLOCK E1 (INITIAL ADDRESS 1, INITIAL REPORTER ADDRESS 2, INITIAL REPORTER CITY, AND INITIAL REPORTER ZIP/POSTAL CODE) HAVE BEEN UPDATED BASED ON THE AVAILABLE INFORMATION RECEIVED ON FEBRUARY 11, 2025.

    Additional Manufacturer Narrative · 0

    BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED.

    Additional Manufacturer Narrative · 0

    BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6) HOSPITAL. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED. BLOCK H2 (ADDITIONAL INFORMATION): BLOCK B5 AND BLOCK E1 (INITIAL ADDRESS 1, INITIAL REPORTER ADDRESS 2, INITIAL REPORTER CITY, AND INITIAL REPORTER ZIP/POSTAL CODE) HAVE BEEN UPDATED BASED ON THE AVAILABLE INFORMATION RECEIVED ON FEBRUARY 11, 2025. BLOCK H11: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITHOUT THE LIGATOR HOUSING, AND THE HANDLE HAS EVIDENCE THAT THE TRIP WIRE WAS SECURED. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS PREMATURE DEPLOYMENT CANNOT BE CONFIRMED SINCE THE LIGATOR HEAD WAS NOT RETURNED FOR ANALYSIS. UPON ANALYSIS OF THE RETURNED COMPONENT, THE HANDLE HAS EVIDENCE THAT THE TRIP WIRE WAS SECURED. SINCE THE LIGATOR HEAD WAS NOT RETURNED FOR ANALYSIS, A PRODUCT ANALYSIS COULD NOT BE PERFORMED TO DETERMINE IF THE DEVICE PRESENTED ANY CONDITION THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ANGUS DURING AN INTERNAL HEMORRHOID LIGATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BAND COULD NOT BE DEPLOYED NORMALLY AS SEVERAL BANDS WERE DEPLOYED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025: DURING THE PROCEDURE, THE BANDS DEPLOYED PREMATURELY. IT WAS NOTED THAT THERE WAS NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ANUS DURING AN INTERNAL HEMORRHOID LIGATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BAND COULD NOT BE DEPLOYED NORMALLY AS SEVERAL BANDS WERE DEPLOYED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 THE ANUS DURING AN INTERNAL HEMORRHOID LIGATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BAND COULD NOT BE DEPLOYED NORMALLY AS SEVERAL BANDS WERE DEPLOYED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025: DURING THE PROCEDURE, THE BANDS DEPLOYED PREMATURELY. IT WAS NOTED THAT THERE WAS NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959651 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0033854979 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male