BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5664492 · Received May 18, 2016

    Report

    Report Number
    3005099803-2016-01395
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 LIGATOR HEAD FOUND ALL SEVEN BANDS PRESENT WITH THE FIRST BAND SLIGHTLY MOVED. THERE WERE NO ISSUES WITH THE IRRIGATION TUBE AND THE LIGATOR HEAD TEETH. THE SUTURE LOOP WAS NOTED TO BE BROKEN AND ATTACHED TO THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THE PROXIMAL LOOP OF THE TRIP WIRE WAS RETRACTED INTO THE HANDLE POST WITH THE CRIMP CAUGHT INSIDE THE POST. THE TRIP WIRE 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 TRIP WIRE. 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 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) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 ENDOSCOPIC VARICEAL BAND LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WAS TURNED MULTIPLE TIMES IN AN ATTEMPT TO DEPLOY THE BAND; HOWEVER, THE BAND FAILED TO DEPLOY. 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 ENDOSCOPIC VARICEAL BAND LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WAS TURNED MULTIPLE TIMES IN AN ATTEMPT TO DEPLOY THE BAND; HOWEVER, THE BAND FAILED TO DEPLOY. 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
    319585 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 18841649

    Patients

    Seq Age Sex Outcome Treatment
    1