BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5730503 · Received June 16, 2016

    Report

    Report Number
    3005099803-2016-01602
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE FOR ANALYSIS WITH RESIDUE PRESENT INDICATING USE. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ONE BAND HAD BEEN DEPLOYED AND WAS NOT RETURNED. THE REMAINING SIX BANDS WERE MOVED OUT OF POSITION AND THE WHITE BAND WAS BROKEN. THE WHITE BAND AND THE LAST BAND WERE CAUGHT UNDER OTHER BANDS. THERE WAS NO ISSUE WITH THE IRRIGATION TUBE. THE LIGATOR TEETH WERE DAMAGED. IT WAS NOTED THAT THE SUTURE WAS REMOVED FROM THE LIGATOR HEAD AND WAS NOT RETURNED. THE PROXIMAL LOOP OF THE TRIP WIRE WAS RETRACTED INTO THE HANDLE POST WITH THE CRIMP CAUGHT INSIDE THE POST. THE TRIPWIRE WAS ONLY WRAPPED HALF A REVOLUTION AROUND THE SPOOL AND WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT. THE SLOT DID NOT PRESENT ANY EVIDENCE OF PREVIOUS SECURING OF THE TRIPWIRE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180 DEGREES, AN AUDIBLE CLICK WAS HEARD AND INDENTS WERE FELT. THERE WERE NO ISSUE NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT APPEARS THAT THE TRIP WIRE WAS NOT PROPERLY TIGHTENED AND SECURED DURING DEVICE SET-UP, AS INSTRUCTED IN THE DFU. FAILURE TO PROPERLY TIGHTEN AND SECURE THE TRIP WIRE MOST LIKELY CONTRIBUTED TO THE COMPLAINT EVENT. THEREFORE, THE MOST PROBABLY ROOT CAUSE IS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS IN THE ESOPHAGUS USED DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WERE TWISTED TOGETHER AND COULD NOT BE RELEASED. 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE 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 IN THE ESOPHAGUS USED DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WERE TWISTED TOGETHER AND COULD NOT BE RELEASED. 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383032 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 18959184

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR