BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2932749 · Received January 29, 2013

    Report

    Report Number
    3005099803-2013-00243
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 24, 2012
    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

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 THE DEVICE WAS FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED. IT WAS ALSO NOTICED THAT THE OVER SHEATH ASSEMBLY WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. THE COMPLAINT DEVICE WAS RETURNED FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE RETURN CONDITION OF THE DEVICE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00243 AND 3005099803-2013-00244 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER THE FIRST RESOLUTION CLIP DEVICE (MR # 3005099803-2013-00243) WAS ADVANCED TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS ABLE TO EVENTUALLY BE SEPARATED, BUT IT IS NOT KNOWN IF IT WAS REMOVED FROM THE PATIENT OR WAS LEFT TO PASS NATURALLY. A SECOND RESOLUTION CLIP DEVICE (MR # 3005099803-2013-00244) WAS THEN USED, BUT THE SAME ISSUE OCCURRED; AFTER DEPLOYMENT, THE CLIP ASSEMBLY INITIALLY FAILED TO DETACH FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD RESOLUTION CLIP DEVICE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00243 AND 3005099803-2013-00244 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER THE FIRST RESOLUTION CLIP DEVICE (MFR # 3005099803-2013-00243) WAS ADVANCED TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS ABLE TO EVENTUALLY BE SEPARATED, BUT IT IS NOT KNOWN IF IT WAS REMOVED FROM THE PATIENT OR WAS LEFT TO PASS NATURALLY. A SECOND RESOLUTION CLIP DEVICE (MFR # 3005099803-2013-00244) WAS THEN USED, BUT THE SAME ISSUE OCCURRED; AFTER DEPLOYMENT, THE CLIP ASSEMBLY INITIALLY FAILED TO DETACH FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD RESOLUTION CLIP DEVICE. 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
    39059 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000349C3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR