BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3212491 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-05633
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    June 12, 2013
    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)(6). (B)(4) FOR THE INVESTIGATION FINDING OF BUSHING BENT DUE TO CLIP MASHED ONTO THE BUSHING. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING AND THE CLIP ASSEMBLY COULD NOT BE DEPLOYED. THE PRONGS COULD NOT BE OPENED OR CLOSED BUT WERE NOT LOCKED INTO THE CAPSULE. THERE WAS A KINK IN THE CONTROL WIRE. THE OVERSHEATH ASSEMBLY WAS NOT RETURNED. 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 TO STOP A BLEED IN THE STOMACH ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS UNABLE TO BE OPENED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING STABLE. NOTE: INVESTIGATION RESULTS REVEALED THE CLIP WAS MASHED ONTO THE BUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313204 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000466C3

    Patients

    Seq Age Sex Outcome Treatment
    1