BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 14627440 · Received June 7, 2022

    Report

    Report Number
    3005099803-2022-03103
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    January 18, 2022
    Report Date
    June 7, 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
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO SPEEDBAND SUPERVIEW SUPER 7 USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE GASTRIC FUNDUS DURING A PROCEDURE TO TREAT GASTROINTESTINAL (GI) HEMORRHAGE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY. A SECOND SPEEDBAND SUPERVIEW SUPER 7 WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. THE PHYSICIAN USED A RESOLUTION CLIP TO STOP THE BLEEDING. IT WAS NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REFERRED TO THE INTENSIVE CARE UNIT (ICU). NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE BANDS HAD MOVED FROM THEIR POSITION AND OVERLAPPED. ADDITIONALLY, IT WAS REPORTED THAT THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTRIC FUNDUS; HOWEVER, PER THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR IFU, THE DEVICE IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION AND THE REPORTED ANATOMY LOCATION IS NOT DESCRIBED IN THE INDICATIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184747 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0026825969 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown