BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 2060926 · Received March 14, 2011

    Report

    Report Number
    3005188751-2011-00028
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE 8.5F AGILIS INTRODUCER AND ONE DILATOR WERE RECEIVED FOR EVALUATION. THE RETURNED INTRODUCER REVEALED A LEAK AT THE VALVE. ADDITIONAL INVESTIGATION REVEALED A ROUND HOLE IN THE TOP HALF OF THE TWO PART SEAL. THE HOLE IN THE SEAL WAS CONSISTENT WITH A NEEDLE PUNCTURE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. PER THE INSTRUCTIONS FOR USE, THE DILATOR SHOULD BE INSERTED INTO THE INTRODUCER FOLLOWED BY THE NEEDLE ASSEMBLY. THE NEEDLE ASSEMBLY SHOULD NOT ENCOUNTER THE HEMOSTASIS SEAL. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE INTRODUCER WAS INSERTED INTO THE PATIENT, AIR WAS ASPIRATED. ANOTHER SHEATH WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    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 3220900

    Patients

    Seq Age Sex Outcome Treatment
    1