BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 2162015 · Received July 11, 2011

    Report

    Report Number
    3005188751-2011-00116
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME AS MFR REPORT#: 3005188751-2011-00117. IT WAS REPORTED THAT DURING PULMONARY VEIN ISOLATION PROCEDURE, WHILE PERFORMING A TRANSSEPTAL PUNCTURE, A PERFORATION OCCURRED IN THE VENTRICLE OUTFLOW TRACT / AORTA. AN ECHOCARDIOGRAM REVEALED A SMALL "JET"; NO PERICARDIAL EFFUSION WAS NOTED. THE PROCEDURE WAS STOPPED AT THIS TIME. THE PATIENT'S BLOOD PRESSURE WAS STABLE AND THERE WERE NO CONSEQUENCES TO THE PATIENT. A FOLLOW UP ECHO WAS PERFORMED WHICH CONFIRMED THE PATIENT WAS OK; THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THE PATIENT WILL RETURN IN 4 WEEKS FOR PULMONARY VEIN ISOLATION.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other BRK TRANSSEPTAL NEEDLE: REORDER (B)(4), LOT UNK