BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3030834 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-02355
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED AS BEING OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED ISSUE OF CLIP WON'T RELEASE. 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

    VISUAL EXAMINATION NOTED THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND NOT RETURNED. THE CONTROL WIRE WAS SEPARATED PER DESIGN. THERE WAS A KINK IN THE CONTROL WIRE AND THE OVER SHEATH ASSEMBLY WAS NOT RETURNED. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND NOT RETURNED WITH THE DEVICE. INVESTIGATION FOUND THE CLIP ASSEMBLY FULLY DEPLOYED AND NOT RETURNED; AND THE CONTROL WIRE KINKED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE MAY HAVE BEEN LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND 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 RESOLUTION CLIP DEVICE WAS USED FOR HEMOSTASIS DURING A COLONOSCOPY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER APPLYING THE CLIP, THE CLIP WOULD NOT RELEASE FROM THE TISSUE. REPORTEDLY THE CLIP WIGGLED AND THEN PULLED FROM THE TISSUE. THE ENTIRE DEVICE AND CLIP WERE REMOVED FROM THE PATIENT AND SERVICE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE WITH A SLIGHT DELAY TO THE CASE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED FOR HEMOSTASIS DURING A COLONOSCOPY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER APPLYING THE CLIP, THE CLIP WOULD NOT RELEASE FROM THE TISSUE. REPORTEDLY THE CLIP WIGGLED AND THEN PULLED FROM THE TISSUE. THE ENTIRE DEVICE AND CLIP WERE REMOVED FROM THE PATIENT AND SERVICE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE WITH A SLIGHT DELAY TO THE CASE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134574 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000372C3

    Patients

    Seq Age Sex Outcome Treatment
    1