BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3980240 · Received August 5, 2014

    Report

    Report Number
    3005099803-2014-02646
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED ISSUE OF BANDS FAILED TO DEPLOY. REPORTED ISSUE OF SUTURE BROKEN. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THE SUTURE WAS INTACT AND FULLY ATTACHED TO THE TRIP WIRE LOOP. ALL SEVEN BANDS REMAINED ON THE LIGATOR HEAD; HOWEVER, THEY WERE MOVED OUT OF POSITION. THE LIGATOR HEAD TEETH WERE VERY DAMAGED AND THE ADAPTOR RING WAS WITHOUT ISSUE. THE TRIP WIRE WAS SECURED IN THE HANDLE ASSEMBLY WITH ITS PROXIMAL END TIGHTLY COILED. THE DISTAL TRIP WIRE LOOP AND SUTURE LOOP WERE PULLED THROUGH THE HANDLE GROMMET. FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED AND NO ISSUES WERE NOTED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BANDS FAILED TO DEPLOY WAS CONFIRMED. HOWEVER, 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) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER 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 IN THE ESOPHAGUS DURING A GASTROSCOPY AND ESOPHAGEAL BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE TURNING THE HANDLE WHEN ATTEMPTING TO DEPLOY THE FIRST BAND. AN AUDIBLE CLICK WAS HEARD; HOWEVER, NO BAND DEPLOYED. ANOTHER ATTEMPT WAS MADE TO DEPLOY THE BAND BUT RESISTANCE WAS AGAIN FELT AND THE BAND DID NOT DEPLOY. THE SUTURE SNAPPED/BROKE AND THE DEVICE WAS REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THE BANDS WERE NOTED TO BE TWISTED ON THE LIGATOR HEAD. 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 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 A GASTROSCOPY AND ESOPHAGEAL BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE TURNING THE HANDLE WHEN ATTEMPTING TO DEPLOY THE FIRST BAND. AN AUDIBLE CLICK WAS HEARD; HOWEVER, NO BAND DEPLOYED. ANOTHER ATTEMPT WAS MADE TO DEPLOY THE BAND BUT RESISTANCE WAS AGAIN FELT AND THE BAND DID NOT DEPLOY. THE SUTURE SNAPPED/BROKE AND THE DEVICE WAS REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THE BANDS WERE NOTED TO BE TWISTED ON THE LIGATOR HEAD. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457370 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16919022

    Patients

    Seq Age Sex Outcome Treatment
    1