BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3201292 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06336
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND ALL SEVEN BANDS LOADED ON THE LIGATOR HEAD; THE LIGATOR HEAD TEETH WERE DAMAGED, AND THE SUTURE HAD PULLED FREE FROM THE FIRST FIVE BANDS. THE TRIP WIRE HAD BEEN CINCHED INTO THE HANDLE. THE TRIP WIRE WAS NOT WOUND AROUND THE SPOOL AND HAD BEEN PULLED OUT OF THE INTRODUCER. FAILURE TO TIGHTEN THE TRIP WIRE COULD ULTIMATELY IMPACT THE DEPLOYMENT ACTIVITY OF THE BANDS. IF SLACK WAS PRESENT IN THE TRIPWIRE DURING THE PROCEDURE, IT COULD CAUSE THE THREAD TO MOVE OVER THE LIGATOR TEETH WITHOUT DEPLOYING THE BANDS PROPERLY AND DAMAGING THE LIGATOR HEAD TEETH, AS FOUND WITH THIS DEVICE. IT CANNOT BE CONFIRMED THAT THE TRIP WIRE WAS NOT SECURED PROPERLY DURING USE; THEREFORE, THE MOST PROBABLE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    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 BAND LIGATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE TARGET VARIX WAS SUCTIONED COMPLETELY INTO THE LIGATING HOUSING, THE PHYSICIAN TRIED TO ROTATE THE HANDLE CLOCKWISE TO DEPLOY THE BAND. HOWEVER, RESISTANCE WAS FELT, AND THE HANDLE WAS NOT ABLE TO ROTATE TO DEPLOY THE BANDS. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION 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 BAND LIGATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE TARGET VARIX WAS SUCTIONED COMPLETELY INTO THE LIGATING HOUSING, THE PHYSICIAN TRIED TO ROTATE THE HANDLE CLOCKWISE TO DEPLOY THE BAND. HOWEVER, RESISTANCE WAS FELT, AND THE HANDLE WAS NOT ABLE TO ROTATE TO DEPLOY THE BANDS. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300694 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 15967996

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR