BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 14255044 · Received April 29, 2022

    Report

    Report Number
    3005099803-2022-02249
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 4, 2022
    Report Date
    October 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    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

    (INITIAL REPORTER FACILITY NAME): (B)(4). (INITIAL REPORTER ADDRESS 2): (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED

    Additional Manufacturer Narrative · 0

    BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK E1 (INITIAL REPORTER ADDRESS 2): (B)(6). BLOCK H6: MEDICAL DEVICE PROBLEM CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (HANDLE ASSEMBLY, LIGATOR HOUSING, AND IRRIGATION TUBE) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE LIGATOR HOUSING HAD SEVEN BANDS ATTACHED, SOME BANDS WERE MOVED AND OVERLAPPED. THE HANDLE SLOT HAD MARKS OF INSERTION OF THE TRIP WIRE. THE RETURNED IRRIGATION TUBE WAS IN GOOD CONDITION. THE PULLING LOOP (SUTURE THREAD), POSSIBLY DURING DEVICE REMOVAL. THE DEVICE WAS OBSERVED UNDER MAGNIFICATION, AND THE LIGATOR HOUSING TEETH WERE BENT/DAMAGED. THE SUTURE HOLE WAS IN GOOD CONDITION. A FUNCTIONAL EVALUATION WAS PERFORMED BY ROTATING THE HANDLE KNOB. IT COULD BE ROTATED WITHOUT ANY PROBLEMS. THE CLICK WAS AUDIBLE, AND INDENTS FELT EACH 180 DEGREES ROTATION. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS UNABLE TO DEPLOY WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE LIGATOR HEAD TEETH WERE BENT/DAMAGED AND THE BANDS ON THE LIGATOR HEAD WERE MOVED. THESE SUGGEST THAT THE DEVICE COULD NOT DEPLOY. THESE CONDITIONS COULD HAVE BEEN GENERATED DUE TO AN EXCESS OF TENSION APPLIED WHEN TRYING TO MAKE THE DEPLOYMENT OF THE BANDS. THIS SITUATION MOVED THE BANDS FROM THEIR PLACE AS IF TWISTING THEM, WHICH CLEARLY INDICATED INABILITY OF THE DEVICE TO DEPLOY THE BANDS. IT IS POSSIBLE THAT THE FUNCTIONALITY OF THE DEVICE WAS AFFECTED IN SOME WAY; PERHAPS AN EXCESS OF FORCE, MANIPULATION, THE TECHNIQUE USED, OR THE PATIENT'S ANATOMICAL CONDITIONS. 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 IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE BAND, THE BAND ROLLED ONE AFTER ANOTHER, WHICH RESULTED TO BANDS UNABLE TO DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE BAND, THE BAND ROLLED ONE AFTER ANOTHER, WHICH RESULTED TO BANDS UNABLE TO DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280997 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0027918338 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown