BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2932769 · Received January 29, 2013

    Report

    Report Number
    3005099803-2013-00356
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE EXACT EVENT DATE IS UNKNOWN HOWEVER; IT WAS REPORTED THAT THE EVENT TOOK PLACE IN EARLY (B)(6) 2012. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 THAT THERE WAS A KINK IN THE CONTROL WIRE AND THE OVER SHEATH ASSEMBLY WAS NOT RETURNED. THE CLIP ASSEMBLY WAS RETURNED FULLY ATTACHED. A FUNCTIONAL ANALYSIS REVEALED THAT THE CLIP ASSEMBLY COULD BE ACTUATED AND DEPLOYED. TWO DISTINCTIVE CLICKS WERE HEARD. THE PRONGS OPENED TO APPROXIMATELY 11 MM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. THE COMPLAINT DEVICE WAS RETURNED WITH THE CLIP ASSEMBLY FULLY ATTACHED. THE KINK IN THE CONTROL WIRE WAS MOST LIKELY CAUSED BY OPERATIONAL/PROCEDURAL FACTORS AND MAY HAVE AFFECTED THE RELEASING OF THE CLIP; THE MOST PROBABLE ROOT CAUSE WILL BE ASSIGNED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY. ACCORDING TO THE COMPLAINANT, AFTER THE RESOLUTION CLIP DEVICE WAS ADVANCED TO THE TARGET TISSUE IN THE CECUM, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE CASE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM 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 RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY. ACCORDING TO THE COMPLAINANT, AFTER THE RESOLUTION CLIP DEVICE WAS ADVANCED TO THE TARGET TISSUE IN THE CECUM, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE CASE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM 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
    39818 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000339C3

    Patients

    Seq Age Sex Outcome Treatment
    1