BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 20794077 · Received November 27, 2024

    Report

    Report Number
    3005099803-2024-06060
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 5, 2024
    Report Date
    September 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF BANDS MISFIRED. IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.

    Additional Manufacturer Narrative · 0

    H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF BANDS MISFIRED. IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED. H2 (ADDITIONAL INFORMATION): B5 AND H6 (DEVICE CODES) HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 30, 2024.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF BANDS MISFIRED. IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF BANDS PREMATURELY DEPLOYED. BLOCK H11: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE TEETH WERE DAMAGED, AND TWO BANDS WERE OVERLAPPED. ADDITIONALLY, THE SLACK WAS TAKEN UP AND IT WAS SECURED TO THE POST. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS UNABLE TO DEPLOY WAS CONFIRMED. UPON ANALYSIS, THE TEETH OF THE DEVICE WERE DAMAGED. THE MARKINGS ON THE LIGATOR HOUSING SUGGEST THAT EXCESSIVE FORCE MAY HAVE BEEN APPLIED DURING USE, POTENTIALLY CAUSING THE DAMAGE. ALTERNATIVELY, THE PROBLEM COULD BE RELATED TO THE TECHNIQUE USED BY THE PHYSICIAN WHEN INSERTING THE DEVICE INTO THE PATIENT, WHICH MAY HAVE CONTRIBUTED TO THE DAMAGE AND AFFECTED THE HANDLE FUNCTIONALITY DURING BAND DEPLOYMENT. IT IS POSSIBLE THAT THE REPORTED PROBLEM OF THE BANDS FAILING TO DEPLOY MIGHT HAVE TO DO WITH THE TECHNIQUE USED BY THE PHYSICIAN OR THE WAY THE DEVICE WAS HANDLED. IT IS POSSIBLE THAT THE WAY IN WHICH THE DEVICE WAS PLACED, OR THE TORTUOSITY DURING THE PROCEDURE, AFFECTED THE FUNCTIONALITY OF THE HANDLE, CAUSING THE BANDS TO FEEL DIFFICULT TO DEPLOY. THE MARKS ON THE LIGATOR HOUSING TEETH IMPLY THAT THE DEVICE MIGHT HAVE BEEN USED WITH TOO MUCH FORCE, OR PERHAPS THIS COULD BE ATTRIBUTED TO THE WAY THE PHYSICIAN WAS ENTERING THE DEVICE THROUGH THE PATIENT, AFFECTING THE FUNCTIONALITY OF THE HANDLE WHEN DEPLOYING THE BANDS. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A BANDING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BANDS ENCOUNTERED "IRREGULAR" DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE BANDS DID NOT DEPLOY OFF THE LIGATOR AND THE BANDS MISFIRED IN AN UNINTENTIONAL LOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A BANDING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BANDS ENCOUNTERED "IRREGULAR" DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 30, 2024: THE SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION. DURING THE PROCEDURE, THE BANDS PREMATURELY DEPLOYED AND ALSO THE BANDS MISFIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A BANDING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BANDS ENCOUNTERED "IRREGULAR" DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 30, 2024: THE SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION. DURING THE PROCEDURE, THE BANDS PREMATURELY DEPLOYED AND ALSO THE BANDS MISFIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370073 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0034149690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown