BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 13541878 · Received February 16, 2022

    Report

    Report Number
    3005099803-2022-00647
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 23, 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
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (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 A1 PATIENT IDENTIFIER: HN: (B)(6). BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: MEDICAL DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. BLOCK H10: INVESTIGATION RESULTS THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE LIGATOR HEAD AND HANDLE ASSEMBLY WERE RETURNED WITH THE DEVICE. IT WAS ALSO NOTED THE TRIP WIRE WAS SECURED BUT THE SLACK WAS NOT TAKEN UP CORRECTLY AND IT WAS ROLLED ON THE HANDLE SLOT. THE LIGATOR HEAD HAD FIVE BANDS ATTACHED. ADDITIONALLY, THE TRIP WIRE WAS CUT. THE SUTURE THREAD HAD THREE KNOTS AND IT WAS ATTACHED TO THE DISTAL TRIP WIRE LOOP. FURTHER INSPECTION SHOWS THAT ONE END OF THE TRIP WIRE REVEALED THAT A MECHANICAL TOOL WAS USED TO PERFORM THE CUT AND THE LIGATOR HEAD TEETH WERE SLIGHTLY BENT. A FUNCTIONAL EVALUATION WAS PERFORMED BY ROTATING THE HANDLE KNOB 180 DEGREES, AN AUDIBLE CLICK WAS HEARD, AND INDENTS WERE FELT. NO DAMAGE OBSERVED TO THE HANDLE ASSEMBLY AND NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. THE LIGATOR HEAD RETURNED WITH FIVE BANDS ATTACHED, MICROSCOPE INSPECTION REVEALED THAT THE LIGATOR HEAD TEETH WERE SLIGHTLY DAMAGED/BENT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. THE VISUAL ASSESSMENT IDENTIFIED THAT THE SLACK WAS ROLLED ON THE HANDLE SLOT INDICATING THAT IT WAS NOT TAKEN UP CORRECTLY AND THIS CONDITION COULD HAVE AFFECTED THE OVERALL PERFORMANCE OF THE DEVICE CAUSING THAT THE TRIP WIRE DID NOT HAVE THE SLIGHT TENSION NECESSARY FOR AN ACCURATE DEPLOYMENT OF THE BANDS, THIS COULD HAVE RESULTED IN IMPROPER DEPLOYMENT OF THE BANDS AND CAUSING MORE TENSION ON THE DEVICE BENDING/DAMAGING THE TEETH. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS FAILURE TO FOLLOW INSTRUCTIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING AN ESOPHAGEAL VARICEAL BLEEDING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE HANDLE WAS ROTATED FROM SECOND TO THIRD BAND; HOWEVER, THE NEXT BAND COULD NOT DEPLOY. THE HANDLE WAS ROTATED AGAIN BUT STILL THE BAND DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT 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 DEVICE WAS USED DURING AN ESOPHAGEAL VARICEAL BLEEDING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE HANDLE WAS ROTATED FROM SECOND TO THIRD BAND; HOWEVER, THE NEXT BAND COULD NOT DEPLOY. THE HANDLE WAS ROTATED AGAIN BUT STILL THE BAND DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON MARCH 02, 2022: IT WAS REPORTED THAT THE PROCEDURE NAME IS ENDOSCOPIC VARICEAL LIGATION (EVL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3273 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0028061540 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 Female