BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRK TRANSSEPTAL NEEDLE, BRK-1 XS

    MDR report key: 2552739 · Received April 24, 2012

    Report

    Report Number
    3005188751-2012-00130
    Event Type
    Injury
    Date Received
    April 24, 2012
    Report Date
    March 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE REVIEW REVEALED NO NONCONFORMING MATERIAL REPORTS AS WELL. 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

    RELATED TO MFR #: 2030404-2012-00114, 2030404-2012-00115, 2030404-2012-00116. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. A BRK-1 TRANSSEPTAL NEEDLE WAS USED TO GAIN LEFT ATRIAL ACCESS. AN INQUIRY STEERABLE AND INQUIRY OPTIMA CATHETER WERE USED TO CREATE GEOMETRY USING THE ENSITE SYSTEM. A COOL PATH DUO CATHETER WAS USED TO PERFORM ABLATION. DURING THE PROCEDURE THE PT EXPERIENCED ST ELEVATIONS AND A DECREASE IN BLOOD PRESSURE. THE PT WAS CARDIOVERTED AND INSTANTLY THE ST ELEVATIONS AND BLOOD PRESSURE RETURNED TO NORMAL. AN ECHOCARDIOGRAM WAS PERFORMED REVEALING A SMALL POSTERIOR EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PT'S CURRENT STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRK TRANSSEPTAL NEEDLE, BRK-1 XS TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION G407212 3607728

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention INQUIRY OPTIMA CATHETER| INQUIRY STEERABLE CATHETER| ENSITE SYSTEM| COOL PATH DUO CATHETER| PREFACE