BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS INTRODUCER, UNKNOWN

    MDR report key: 2120244 · Received June 7, 2011

    Report

    Report Number
    3005188751-2011-00070
    Event Type
    Injury
    Date Received
    June 7, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISIION
    Product Code
    DYB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BETWEEN MAY 2005 AND AUGUST 2007. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND 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. ARYA, ET AL. LONG-TERM RESULTS AND THE PREDICTORS OF OUTCOME OF CATHETER ABLATION OF ATRIAL FIBRILLATION USING STEERABLE SHEATH CATHETER NAVIGATION AFTER SINGLE PROCEDURE IN 674 PATIENTS. EUROPACE (2010) 12, 173-180.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT TAMPONADE OCCURRED. THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION FOR A CIRCUMFERENTIAL LEFT ATRIAL PULMONARY VEIN ABLATION. AN AGILIS STEERABLE SHEATH WAS USED IN THE PROCEDURE. THE TAMPONADE WAS NOTED DURING OR IMMEDIATELY AFTER ABLATION. THE PATIENT WAS TREATED WITH SUBXYPHOID PUNCTURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS INTRODUCER, UNKNOWN AGILIS INTRODUCER, UNK. DYB ST. JUDE MEDICAL, AF DIVISIION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other