BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3973229 · Received August 1, 2014

    Report

    Report Number
    3005099803-2014-02651
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CLIP FAILED TO RELEASE FROM THE CATHETER. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-02651 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2014-02653 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED IN THE LARGE INTESTINE DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. ANOTHER RESOLUTION CLIP DEVICE WAS OPENED AND USED; HOWEVER, THE SAME ISSUE OCCURRED. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER TWO RESOLUTION CLIP DEVICES WITHOUT ANY ISSUES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451182 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000567C3

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR