BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 15804347 · Received November 16, 2022

    Report

    Report Number
    3005099803-2022-06644
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A04 CAPTURES THE REPORTABLE EVENT OF BANDS MOVED FROM THEIR POSITION AND INTERTWINED. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE RETURNED LIGATOR HEAD HAD ALL SEVEN BANDS ATTACHED AND SOME OF THEM WERE MOVED FROM ITS POSITION AND OVERLAPPED. THESE FINDINGS WERE CONSISTENT WITH THE FINDINGS PER MEDIA INSPECTION ON THE PROVIDED PHOTOS. A POUCH WITH THE UPN AND BATCH/LOT WHICH MATCHED TO THE REPORTED PRODUCT DETAILS WAS ALSO OBSERVED IN THE PHOTO. THE TRIP WIRE WAS SECURED, AND IT WAS ATTACHED TO THE LOOP, INDICATING THAT THE DEVICE WAS USED. THE BANDS WERE NOT BROKEN/DAMAGED. THE RETURNED IRRIGATION TUBE WAS IN GOOD CONDITION. A FUNCTIONAL EVALUATION WAS PERFORMED BY ROTATING THE HANDLE KNOB. IT COULD BE ROTATED WITHOUT ANY PROBLEMS. NO PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS BROKEN/DAMAGED WAS NOT CONFIRMED; HOWEVER, UPON ANALYSIS, IT WAS FOUND THAT THE BANDS WERE MOVED FROM ITS POSITION AND OVERLAPPED. UPON ANALYSIS, IT WAS FOUND THAT THE BANDS WERE NOT BROKEN/DAMAGED. THESE SUGGEST THAT THE DEVICE COULD NOT DEPLOY. THESE CONDITIONS COULD HAVE BEEN GENERATED DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE WHICH COULD HAVE AFFECTED THE OVERALL PERFORMANCE OF THE DEVICE LEADING TO THE REPORTED EVENT, MAKING THE BANDS OVERLAPPED, MOVES FROM ITS POSITION AND LEADING TO INABILITY OF THE DEVICE TO DEPLOY THE BANDS AND UNABLE TO CONTINUE THE OPERATION. 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 ESOPHAGEAL VARICES LIGATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, UPON UNPACKING OF THE DEVICE, IT WAS NOTICED THAT THERE WERE TWO BANDS THAT WERE MOVED FROM THEIR POSITION. 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. PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED TWO BANDS INTERTWINED AND MOVED FROM THEIR POSITION.

    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 ESOPHAGEAL VARICES LIGATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, UPON UNPACKING OF THE DEVICE, IT WAS NOTICED THAT THERE WERE TWO BANDS THAT WERE MOVED FROM THEIR POSITION. 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. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED TWO BANDS INTERTWINED AND MOVED FROM THEIR POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375021 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0028708227 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown