BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2901012 · Received January 8, 2013

    Report

    Report Number
    3005099803-2013-00036
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ADVANCING THE DEVICE TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS "CLIPPED DOWN ON THE TISSUE." HOWEVER, ONCE PERFORMED, THE CLIP ASSEMBLY WAS NOT ABLE TO BE OPENED TO REPOSITION. AT THIS TIME, THE DECISION WAS MADE TO COMPLETE THE DEPLOYMENT, BUT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WITH ATTACHED CLIP WAS WITHDRAWN FROM THE PATIENT AND REMOVED FROM SERVICE, AND THEN THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. 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
    9150 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000325C3

    Patients

    Seq Age Sex Outcome Treatment
    1