BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2130128 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02147
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RETURNED DEVICE FOUND THAT THERE WAS A KINK IN THE CONTROL WIRE. THE CLIP ASSEMBLY WAS DEPLOYED AND NOT RETURNED. THE REPORTED EVENT OF CLIP FAILED TO RELEASE WAS NOT ABLE TO BE CONFIRMED SINCE THE CLIP ASSEMBLY WAS DEPLOYED AND NOT RETURNED. HOWEVER, THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE, AS EVIDENT OF 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #'S 3005099803-2011-02145, 3005099803-2011-02146, 3005099803-2011-02148 AND 3005099803-2011-02149 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FIVE RESOLUTION CLIP DEVICES WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE FIRST CLIP WAS ADVANCED THROUGH THE SCOPE AND EXITED IN THE PATIENT'S COLON WITH NO ISSUE. HOWEVER, ALTHOUGH THE CLIP GRASPED TISSUE AT THE TARGET SITE, IT FAILED TO RELEASE FROM THE CATHETER. THE PHYSICIAN SHOOK THE SCOPE GENTLY, AT WHICH TIME THE CLIP DISENGAGED AND FELL INTO THE PATIENT. THE CLIP WAS NOT RETRIEVED. THIS SAME ISSUE WAS REPORTED TO HAVE OCCURRED WITH FOUR ADDITIONAL RESOLUTION CLIPS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #'S 3005099803-2011-02145, 3005099803-2011-02146, 3005099803-2011-02148 AND 3005099803-2011-02149 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FIVE RESOLUTION CLIP DEVICES WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE FIRST CLIP WAS ADVANCED THROUGH THE SCOPE AND EXITED IN THE PATIENT'S COLON WITH NO ISSUE. HOWEVER, ALTHOUGH THE CLIP GRASPED TISSUE AT THE TARGET SITE, IT FAILED TO RELEASE FROM THE CATHETER. THE PHYSICIAN SHOOK THE SCOPE GENTLY, AT WHICH TIME THE CLIP DISENGAGED AND FELL INTO THE PATIENT. THE CLIP WAS NOT RETRIEVED. THIS SAME ISSUE WAS REPORTED TO HAVE OCCURRED WITH FOUR ADDITIONAL RESOLUTION CLIPS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 11020702C2

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR