BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2822522 · Received November 7, 2012

    Report

    Report Number
    3005099803-2012-05102
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN. HOWEVER, PATIENT WAS OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO SEPARATE FROM CATHETER. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05102, 3005099803-2012-05103, 3005099803-2012-05104, AND 3005099803-2012-05105 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SAME ISSUE OCCURRED WITH FOUR RESOLUTION CLIP DEVICES. REPORTEDLY, POST DEPLOYMENT, THE CLIP ASSEMBLIES FROM EACH OF THE FOUR DEVICES FAILED TO RELEASE FROM ITS RESPECTIVE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. THE CASE WAS DELAYED APPROXIMATELY 10 MINUTES AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000272C2

    Patients

    Seq Age Sex Outcome Treatment
    1