BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL PATH ABLATION CATHETER

    MDR report key: 2041975 · Received March 31, 2011

    Report

    Report Number
    2030404-2011-00089
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 CASE AS MFR REPORT 2030404-2011-00002. IT WAS REPORTED A STROKE OCCURRED 5 DAYS AFTER A CARDIAC ABLATION PROCEDURE FOR RIGHT ATRIAL FLUTTER WHICH WAS PERFORMED USING AN ARRAY CATHETER AND A THERAPY COOL PATH ABLATION CATHETER. THE ABLATION PROCEDURE WAS UNSUCCESSFUL IN CHANGING THE PRESENTING ARRHYTHMIA AND THE PATIENT WAS CARDIOVERTED AFTER ALL DEVICES WERE REMOVED. IMMEDIATELY FOLLOWING THE PROCEDURE THE PATIENT WAS IN SINUS RHYTHM. FOLLOW UP INFORMATION REVEALED THE PATIENT HAS LEFT SIDED WEAKNESS AND DIFFICULTY SPEAKING AS A RESULT OF THE REPORTED STROKE. A NEUROLOGIST DIAGNOSED AN ACUTE CVA FOLLOWING ONSET OF SYMPTOMS ON (B)(6) 2011 AND A CT SCAN WHICH WAS PERFORMED THE SAME DAY. THE PATIENT WAS ON COUMADIN PREPROCEDURE BUT IT WAS STOPPED BEFORE THE ABLATION AND NEVER RESTARTED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH ABLATION CATHETER NONE OAD ST. JUDE MEDICAL, IRVINE 83327 3262212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EP WORKMATE SYSTEM| ENSITE ARRAY CATHETER| IBI T9 GENERATOR