BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3963424 · Received July 29, 2014

    Report

    Report Number
    3005099803-2014-02579
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 24, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULT OF CLIP MASHED ONTO BUSHING. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. THE CLIP ASSEMBLY WAS DETACHED FROM BUSHING WHEN THE CONTROL WIRE WAS ACTUATED; THUS, THE PRONGS COULD NOT BE OPENED BECAUSE THE CLIP ASSEMBLY WAS DEPLOYED. THE PRONGS WERE NOT LOCKED INTO THE CAPSULE. A KINK WAS NOTED IN THE CONTROL WIRE. IT WAS ALSO NOTED THAT THE OVER SHEATH 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 AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT OPEN AND WAS DANGLING FROM THE TIP OF THE CATHETER IN A CLOSED POSITION. THE CLIP WAS REMOVED FROM THE PATIENT. THE PHYSICIAN OPENED AND USED ANOTHER RESOLUTION CLIP DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE CLIP WAS MASHED ON THE BUSHING, THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441990 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000659C3

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR