BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 14627441 · Received June 7, 2022

    Report

    Report Number
    3005099803-2022-03104
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    January 18, 2022
    Report Date
    September 16, 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.

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF THE PATIENT BEING REFERRED TO THE ICU. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (HANDLE ASSEMBLY AND LIGATOR HEAD) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THERE WERE FIVE BANDS ATTACHED IN THE LIGATOR HEAD, AND SOME OF THEM WERE OVERLAPPED. ONE BAND WAS FOUND BROKEN. THE SUTURE THREAD WAS IN GOOD CONDITION. THE DEVICE WAS OBSERVED UNDER MAGNIFICATION, AND THE LIGATOR HEAD TEETH WERE BENT/DAMAGED. BANDS WERE FOUND CRACKED/DAMAGED. THE SUTURE HOLE OF THE LIGATOR HOUSING WAS IN GOOD CONDITION. THE HANDLE HAD MARKS OF THE INSERTION OF THE TRIP WIRE. 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. PER MEDIA ANALYSIS BASED ON THE PROVIDED PHOTOS, A POUCH AND A LIGATOR HOUSING WITH THE BANDS MOVED AND OVERLAPPED, AND THE HANDLE WITH THE TRIP WIRE INSERTED. 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, OVERLAPPED, AND BROKEN. THESE SUGGEST THAT THE DEVICE COULD NOT DEPLOY. THESE CONDITIONS COULD HAVE BEEN GENERATED DUE TO AN EXCESS TENSIONS 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 THE INABILITY OF THE DEVICE TO DEPLOY. IT IS POSSIBLE THAT THE FUNCTIONALITY OF THE DEVICE HAS BEEN AFFECTED IN SOME WAY; PERHAPS AN EXCESS OF FORCE, MANIPULATION, THE TECHNIQUE USED, OR THE PATIENT'S ANATOMICAL CONDITIONS COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) AS THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTRIC FUNDUS; HOWEVER, PER THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR INSTRUCTIONS FOR USE, 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.

    Description of Event or Problem · 0

    HIS 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.

    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 JANUARY 18, 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
    184748 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0026825969 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown