BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 2121901 · Received May 23, 2011

    Report

    Report Number
    3005188751-2011-00056
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR - ONE 8.5F AGILIS INTRODUCER AND ONE DILATOR WERE RECEIVED FOR EVAL. VISUAL INSPECTION OF THE RETURNED INTRODUCER CONFIRMED THE EXTENSION TUBING WAS DETACHED. FURTHER INVESTIGATION CONFIRMED THERE WAS NO DRIED SOLVENT ON THE TUBE OR WITHIN THE PORT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH MFG AS THE EVENT IS RELATED TO A MFG NON-CONFORMANCE. THIS DEVICE WAS MANUFACTURED PRIOR TO A QUALITY IMPROVEMENT PROJECT THAT WAS INITIATED TO ADDRESS DETACHMENTS OF THE STOPCOCK ASSEMBLY. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SIDEPORT DETACHED FROM THE INTRODUCER AND BLOOD WAS NOTED IN THE SHEATH. THE DEVICE WAS REPLACED WITH NO CONSEQUENCES TO THE PT. ADDITIONAL INFO WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL AGILIS NXT, 8.5F MED CRL DYB ST. JUDE MEDICAL, AF DIVISION 408310 3220894

    Patients

    Seq Age Sex Outcome Treatment
    1