BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4009130 · Received August 14, 2014

    Report

    Report Number
    3005099803-2014-02808
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 25, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) BANDS FAILED TO DEPLOY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THERE WAS NO ISSUE NOTED WITH THE EXTENSION TUBE. THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED TO BOTH THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. ONE BAND HAD BEEN DEPLOYED AND NOT RETURNED, WHILE FIVE OF THE REMAINING BANDS WERE MOVED OUT OF POSITION. THE LIGATOR HEAD TEETH PRESENTED DAMAGE. THE TRIP WIRE WAS CAUGHT BETWEEN THE HANDLE BRACKET AND SPOOL. IT WAS ALSO NOTED THAT THE TRIP WIRE HAD GOUGED THE SPOOL EDGE. THERE WAS NO EVIDENCE PRESENT THAT THE TRIP WIRE HAD BEEN SECURED DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS ATTEMPTED; HOWEVER, THE TRIP WIRE WAS WEDGED TIGHTLY MAKING THE HANDLE KNOB UNABLE TO ROTATE. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BANDS FAILED TO DEPLOY WAS NOT ABLE TO BE CONFIRMED. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS CINCHED IN THE HANDLE SLOT AS INSTRUCTED IN THE DFU, WHICH IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS TO LIGATE VARICES DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND WOULD NOT DEPLOY WHEN AN ATTEMPT TO RELEASE THE BAND WAS DONE. THE SUTURE APPEARED TANGLED AT THE BAND. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS TO LIGATE VARICES DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND WOULD NOT DEPLOY WHEN AN ATTEMPT TO RELEASE THE BAND WAS DONE. THE SUTURE APPEARED TANGLED AT THE BAND. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486975 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 16922749

    Patients

    Seq Age Sex Outcome Treatment
    1