BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3926415 · Received July 10, 2014

    Report

    Report Number
    3005099803-2014-02488
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF 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 # 3005099803-2014-02485 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2014-02488 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER, THE CLIPS WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. ANOTHER CLIP WAS USED, BUT THE SAME ISSUE OCCURRED. IN THE PHYSICIAN¿S ASSESSMENT THE BLEED WAS MINIMIZED ENOUGH BY THE TWO ATTEMPTS TO CLIP TARGET SITE AND DECIDED COMPLETE THE PROCEDURE WITHOUT FURTHER INTERVENTION. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404623 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000752C3

    Patients

    Seq Age Sex Outcome Treatment
    1