BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 15521872 · Received September 30, 2022

    Report

    Report Number
    3005099803-2022-05724
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 13, 2022
    Report Date
    November 17, 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

    (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF BROKEN SUTURE. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (HANDLE ASSEMBLY, LIGATOR HEAD, AND IRRIGATION TUBE) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE LIGATOR HEAD HAD FIVE BANDS ATTACHED AND SOME OF THEM WERE MOVED FROM THEIR POSITIONS. THE SUTURE THREAD WAS BROKEN. THE HANDLE SLOT HAD MARKS OF INSERTION OF THE TRIP WIRE. THE LIGATOR HEAD TEETH WERE FOUND BENT/DAMAGED. THE SUTURE HOLE OF THE LIGATOR HOUSING AND THE RETURNED IRRIGATION TUBE WERE 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 SUTURE BROKEN WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE SUTURE WAS BROKEN AT THE PULLING LOOP. THIS CONDITION COULD HAVE BEEN GENERATED DUE TO AN EXCESS TENSION BASED ON THE ASPECT OF THE SUTURE TEAR. MOVED BANDS AND BENT LIGATOR HOUSING TEETH COULD ALSO HAVE GENERATED DUE TO THE TENSION APPLIED WHEN TRYING TO MAKE THE DEPLOYMENT OF THE BANDS; PERHAPS AN EXCESS OF FORCE, MANIPULATION OR THE TECHNIQUE USED. 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 A VARICOSE VEIN LIGATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SUTURE BROKE. 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 A VARICOSE VEIN LIGATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SUTURE BROKE. 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
    2383793 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0028767346 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male