BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4079804 · Received September 11, 2014

    Report

    Report Number
    3005099803-2014-02929
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    May 15, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS OF BANDS FAILED TO DEPLOY. EVALUATION FINDINGS OF SUTURE BROKEN. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. DARK RED RESIDUE WAS NOTED INSIDE THE EXTENSION TUBE AND LIGATOR HEAD. THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED TO BOTH THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THREE BANDS HAD BEEN DEPLOYED AND NOT RETURNED. THE REMAINING BANDS WERE MOVED OUT OF POSITION WHICH IS CONSISTENT WITH THE BANDS FAILED TO DEPLOY. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. THERE WAS NO EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED IN THE HANDLE ASSEMBLY SLOT DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB 180º AND NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. 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) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02558, 3005099803-2014-02930 AND 3005099803-2014-02929 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT THREE SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTED THAT FOR TWO DEVICES (REFER TO MFR REPORT # 3005099803-2014-02558 AND THIS REPORT) IT WAS IMPOSSIBLE TO ROTATE THE HANDLE. THE PHYSICIAN NOTED THAT THE THIRD DEVICE (REFER TO MFR REPORT #3005099803-2014-02930), WAS IMPOSSIBLE TO PULL THE SLACK OUT OF THE TRIPWIRE. ALL THREE EVENTS OCCURRED OUTSIDE THE PATIENT, DURING PREPARATION PRIOR TO THE DEVICE BEING INSTALLED INTO THE ENDOSCOPE. 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 GOOD. NOTE: INVESTIGATION RESULTS REVEALED THAT THE SUTURE WAS BROKEN AND THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH BANDS FAILED TO DEPLOY, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562070 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16821738

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR