BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 13774462 · Received March 15, 2022

    Report

    Report Number
    3005099803-2022-01255
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 16, 2022
    Report Date
    April 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE PROBLEM CODE: (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF SUTURE BREAK. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (HANDLE ASSEMBLY AND LIGATOR HEAD) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE POST DID NOT SHOW INSERTION MARKS OF THE TRIP WIRE, INDICATING THAT THE TRIP WIRE WAS NOT SECURED. ADDITIONALLY, THE SLACK'S RETURNED POSITION SUGGESTED THAT IT WAS NOT TAKEN UP CORRECTLY. THE SUTURE THREAD WAS BROKEN AND CONTAINED SEVEN KNOTS. THE RETURNED LIGATOR HEAD HAD FIVE BANDS ATTACHED, SOME OF THEM HAD MOVED FROM THEIR POSITION. THE DEVICE WAS OBSERVED UNDER MAGNIFICATION AND THE LIGATOR HEAD TEETH WERE FOUND IN GOOD CONDITION, INCLUDING THE SUTURE HOLE. 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, IT WAS OBSERVED THAT THE SUTURE THREAD WAS BROKEN AND THE LIGATOR HEAD HAD FIVE BANDS. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF SUTURE BREAK WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE SUTURE THREAD WAS BROKEN. THE BANDS HAD MOVED ALSO. ADDITIONALLY, EVIDENCE WAS FOUND THAT THE SLACK WAS NOT TAKEN UP CORRECTLY AND THE TRIP WIRE WAS NOT SECURED; HOWEVER, THE INSTRUCTIONS FOR USE (IFU) INDICATES, "TAKE UP SLACK BY PULLING PROXIMAL END OF TRIP WIRE ON HANDLE UNIT." AND "SECURE TRIP WIRE IN SLOT ON HANDLE UNIT." THESE CONDITIONS COULD HAVE CAUSED THAT THE DEVICE DID NOT WORK AS INTENDED, RESULTING IN A LOSS OF FUNCTIONALITY THAT MAY HAVE BROKEN THE SUTURE THREAD. IT IS VERY IMPORTANT TO THE CORRECT OPERATION OF THE DEVICE THAT THE USER TAKE UP THE SLACK AND SECURE THE TRIP WIRE CORRECTLY, OTHERWISE IT WILL SLIDE INACCURATELY, AND IT WILL NOT HAVE THE REQUIRED PRECISION, SO, THE BANDS CANNOT BE DEPLOYED AS INTENDED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE ENCOUNTERED PROBLEMS WILL BE DOCUMENTED AS FAILURE TO FOLLOW INSTRUCTIONS DUE TO PROBLEMS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. 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). BLOCK H11 (CORRECTION): BLOCK E1 (INITIAL REPORTER PHONE) HAS BEEN CORRECTED FROM (B)(6)TO (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE GASTRIC VENOUS DURING A VARICOSE LIGATION OF THE GASTRIC FUNDUS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE WIRE OF THE BANDS WAS FRACTURED. THE DEVICE WAS REMOVED, AND 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: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE SUTURE WIRE WAS BROKEN. ADDITIONALLY, IT WAS REPORTED THAT THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTRIC VENOUS; 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 DESCRIBE IN THE INDICATIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE GASTRIC VENOUS DURING A VARICOSE LIGATION OF THE GASTRIC FUNDUS PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE WIRE OF THE BANDS WAS FRACTURED. THE DEVICE WAS REMOVED, AND 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: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE SUTURE WIRE WAS BROKEN. ADDITIONALLY, IT WAS REPORTED THAT THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTRIC VENOUS; 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 DESCRIBE IN THE INDICATIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938649 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0027733531 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male