BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3895119 · Received June 25, 2014

    Report

    Report Number
    3005099803-2014-02297
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE WAS DISPOSED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-02295 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2014-02296 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2014-02297 PERTAINS TO THE THIRD RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH OF THE FIRST CLIP WAS REMOVED AND THEN INSERTED INTO THE PATIENT. ONCE INSIDE THE PATIENT, THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. A SECOND AND THIRD CLIP WAS WERE USED, ALSO REMOVING THE SHEATH BEFORE BEING INSERTED INTO THE SCOPE, BUT THE SAME ISSUE OCCURRED. THEREFORE, ANOTHER RESOLUTION CLIP DEVICE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371547 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000539C3

    Patients

    Seq Age Sex Outcome Treatment
    1