BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL

    MDR report key: 1000768 · Received February 21, 2008

    Report

    Report Number
    2182269-2008-00060
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE AGILIS STEERABLE INTRODUCER WAS RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. TESTING IDENTIFIED A LEAK AT THE HEMOSTASIS VALVE. THE HEMOSTASIS CAP WAS REMOVED WHICH REVEALED A CUT/TEAR IN BOTH HALVES OF THE TWO PART SEAL SYSTEM. IT IS UNCERTAIN HOW OR WHEN THE CUT/TEAR OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN CROSSED THE SEPTUM AND WHEN HE ASPIRATED THE SHEATH, THERE WAS AIR IN THE SYSTEM. THE SHEATH APPEARS AS IF IT HAS STRETCHED AT THE SEAM, JUST DISTAL TO THE HANDLE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL AGILIS NXT, 8.5F DYB ST. JUDE MEDICAL NA 2035966

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK