BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5057029 · Received September 4, 2015

    Report

    Report Number
    3005099803-2015-02544
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO RESIDUE AND THERE WAS NO ISSUE WITH THE EXTENSION TUBE. IT WAS NOTED THAT THE SUTURE WAS STILL INTACT AND ATTACHED TO THE TRIP WIRE LOOP. ALL SEVEN LIGATION BANDS WERE PRESENT ON THE LIGATOR HEAD; HOWEVER, THE FIRST BLUE BAND WAS MOVED OUT OF POSITION. IT WAS ALSO NOTED THAT ONE TOOTH OF THE LIGATOR HEAD WAS DAMAGED. IT WAS OBSERVED THAT THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT; HOWEVER, THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. 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 DEVICE, IT APPEARS THAT THE TRIP WIRE WAS NOT PROPERLY TIGHTENED AND SECURED DURING DEVICE SET-UP. THIS FAILURE TO PROPERLY TIGHTEN AND SECURE THE TRIP WIRE MOST LIKELY IMPACTED THE TIMING OF BAND DEPLOYMENT 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.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF (B)(6). (B)(4). 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.

    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 DURING AN ESOPHAGEAL VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED INSIDE THE PATIENT. THE DEVICE WAS THEN REMOVED FROM THE SCOPE AND THE PATIENT; OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE SUTURE SNAPPED. 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 USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED INSIDE THE PATIENT. THE DEVICE WAS THEN REMOVED FROM THE SCOPE AND THE PATIENT; OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE SUTURE SNAPPED. 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
    588922 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 18099704

    Patients

    Seq Age Sex Outcome Treatment
    1