BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5262218 · Received December 2, 2015

    Report

    Report Number
    3005099803-2015-03364
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 10, 2015
    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

    PROBLEM CODE (B)(4) RELATES TO THE REPORTED ISSUE OF BANDS FAILED TO DEPLOY. 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.

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE FOR ANALYSIS WITH RESIDUE PRESENT INDICATING USE OR HANDLING. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ALL 7 BANDS PRESENT WITH 6 BANDS MOVED OUT OF POSITION. THERE WAS NO ISSUE WITH THE IRRIGATION TUBE. THE SUTURE WAS NOTED TO BE BROKEN AND WITH PORTIONS ATTACHED BOTH THE TRIP WIRE LOOP AND LIGATOR HEAD. IT WAS NOTICED THAT THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED BOTH THE TRIP WIRE LOOP AND LIGATOR HEAD. THE TRIP WIRE WAS NOT SECURED INTO THE HANDLE SLOT. THE HANDLE SLOT PRESENTED SLIGHT EVIDENCE THAT THE TRIP WIRE HAD BEEN PREVIOUSLY SECURED. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180 DEGREES AND AN AUDIBLE CLICK WAS HEARD, NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. IT IS POSSIBLE THE TRIP WIRE WAS NOT TIGHTENED APPROPRIATELY OR THE WIRE WAS NOT WOUND PROPERLY AROUND THE SPOOL, WHICH WOULD CAUSE THE SYSTEM TIMING TO BE INCORRECT ULTIMATELY IMPACTING THE DEPLOYMENT ACTIVITY OF THE BANDS, HOWEVER, IT CANNOT BE CONFIRMED THAT THE TRIP WIRE WAS NOT SECURED PROPERLY DURING USE. GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND 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 USED DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BAND 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
    790514 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 17838180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR