BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2903531 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00108
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 NOTED THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND NOT RETURNED. THERE WAS A KINK IN THE CONTROL WIRE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, IT IS LIKELY THAT THE DIFFICULTIES EXPERIENCED DURING DEPLOYMENT WERE DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY WITHIN THE ASCENDING COLON, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED, BUT IT FAILED TO RELEASE FROM THE DELIVERY CATHETER. REPORTEDLY, THE PHYSICIAN WAS ABLE TO MANIPULATE THE SCOPE TO RELEASE THE CLIP. AFTER SEPARATION, THE CLIP ASSEMBLY REMAINED ATTACHED TO THE TARGET TISSUE WHICH WAS SUFFICIENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING 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 WITHIN THE ASCENDING COLON, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED, BUT IT FAILED TO RELEASE FROM THE DELIVERY CATHETER. REPORTEDLY, THE PHYSICIAN WAS ABLE TO MANIPULATE THE SCOPE TO RELEASE THE CLIP. AFTER SEPARATION, THE CLIP ASSEMBLY REMAINED ATTACHED TO THE TARGET TISSUE WHICH WAS SUFFICIENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10988 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000123C2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR