BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3090438 · Received May 2, 2013

    Report

    Report Number
    3005099803-2013-03135
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 2, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING AND COULD NOT BE DEPLOYED. THE CLIP ARMS WERE LOCKED INTO THE CAPSULE AND COULD NOT BE OPENED OR CLOSED. THE OVERSHEATH ASSEMBLY WAS NOT RETURNED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE OF CLIP DEPLOYED PREMATURELY 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 USE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED IN THE STOMACH ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ABLE TO BE OPENED AND PRIOR TO GRASPING TISSUE IT PREMATURELY DEPLOYED. THE CLIP FELL IN THE PATIENT IN AN OPEN STATE. THE CLIP WAS IN THE PATIENT TO PASS NATURALLY. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING FINE. NOTE: INVESTIGATION RESULTS REVEALED THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. THE COMPLAINANT REPORTED THE CORRECT COMPLAINT DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192629 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000389C3

    Patients

    Seq Age Sex Outcome Treatment
    1 43