BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2855058 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05499
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED FULLY DEPLOYED. THE CLIP ASSEMBLY WAS RECEIVED FOR ANALYSIS. ADDITIONALLY, THE CONTROL WIRE, WHICH RETURNED KINKED, WAS SEPARATED AS PER DESIGN. THE CAPSULE TABS WERE PARTIALLY OPEN AND THE PRONGS REMAINED OPEN TO APPROXIMATELY 11MM. FURTHER ANALYSIS REVEALED THAT THE SLIDER COVER WAS BROKE AND THE CROSS PIN HAD DETACHED FROM THE SLIDER. FURTHERMORE, THE OVERSHEATH WITH BLUE SHEATH GRIP WAS NOT RETURNED WITH THE DEVICE. THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER WAS NOT ABLE TO BE CONFIRMED SINCE THE DEVICE WAS RECEIVED WITH THE CLIP ASSEMBLY FULLY DEPLOYED. HOWEVER, THE EVENT MAY HAVE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AS EVIDENCED BY THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP LOCKED AND DEPLOYED ONTO THE TISSUE HOWEVER; THE CLIP WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY, THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED WITH THE DELIVERY SYSTEM. THE CASE WAS THEN COMPLETED WITH ANOTHER RESOLUTION CLIP 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP LOCKED AND DEPLOYED ONTO THE TISSUE HOWEVER; THE CLIP WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY, THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED WITH THE DELIVERY SYSTEM. THE CASE WAS THEN COMPLETED WITH ANOTHER RESOLUTION CLIP 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP LOCKED AND DEPLOYED ONTO THE TISSUE HOWEVER; THE CLIP WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY, THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED WITH THE DELIVERY SYSTEM. THE CASE WAS THEN COMPLETED WITH ANOTHER RESOLUTION CLIP 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000333C3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR