BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5056996 · Received September 4, 2015

    Report

    Report Number
    3005099803-2015-02505
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE FOR ANALYSIS WITH RESIDUE PRESENT ON THE DEVICE INDICATING USE OR HANDLING. A VISUAL EXAMINATION OF THE LIGATOR HEAD FOUND SIX (6) BANDS PRESENT WITH FIVE (5) OF THE BANDS MOVED OUT OF POSITION. IT WAS NOTICED THAT ONE (1) BAND HAD BEEN DEPLOYED AND NOT RETURNED . THERE WAS NO ISSUE WITH THE IRRIGATION TUBE. THE LIGATOR TEETH WAS NOTED TO BE DAMAGED AND BROKEN. THE SUTURE WAS OBSERVED TO BE INTACT AND ATTACHED TO THE TRIPWIRE LOOP. IT WAS ALSO FOUND THAT TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE POST WHEREIN THE SLOT DID NOT PRESENT ANY EVIDENCE OF PREVIOUS SECURING OF THE TRIP WIRE AND THE TRIP WIRE WAS NOTICED TO HAVE BEEN CAUGHT BETWEEN THE HANDLE BRACKET AND SPOOL. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180 DEGREES, INDENTS WERE FELT, AND AN AUDIBLE CLICK WAS HEARD; NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT APPEARS THAT THE USER DID NOT PROPERLY TIGHTEN AND SECURE THE TRIP WIRE DURING DEVICE SET-UP, AS INSTRUCTED IN THE DFU. FAILURE TO PROPERLY TIGHTEN AND SECURE THE TRIP WIRE MOST LIKELY IMPACTED THE TIMING OF BAND DEPLOYMENT, DAMAGED THE LIGATOR TEETH, AND CONTRIBUTED TO THE COMPLAINT EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. 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 · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2015 THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY ONTO THE VARIX. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 11, 2015 THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY ONTO THE VARIX. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587482 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 17746096

    Patients

    Seq Age Sex Outcome Treatment
    1