BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

    MDR report key: 2230708 · Received August 17, 2011

    Report

    Report Number
    2030404-2011-00235
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG 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 EVENT AS MFR REPORT 3005188751-2011-00141. IT WAS REPORTED AT THE COMPLETION OF A VENTRICULAR TACHYCARDIA (VT) CARDIAC ABLATION PROCEDURE THE PT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS NOTED. PRIOR THE VT ABLATION PROCEDURE THE PT HAD A NON SJM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTED THAT MORNING WITH NO REPORTED HYPOTENSIVE EVENTS. THE PHYSICIAN PERFORMED THE VT CARDIAC ABLATION PROCEDURE USING THE ENSITE NAVX AND A NON SJM FIXED DEFIBRILLATOR LEAD IN THE ATRIA AS THE POSITIONAL REFERENCE. A THERAPY COOL FLEX CATHETER WAS PLACED IN THE LEFT VENTRICLE USING RETROGRADE APPROACH AND A 6F SUPREME EP CATHETER WAS PLACED IN THE RIGHT VENTRICLE FOR THE PROCEDURE. AT THE COMPLETION OF THE ABLATION PROCEDURE JUST PRIOR REMOVING THE CATHETERS THE PT BECAME HYPOTENSIVE. A PERICARDIAL EFFUSION WAS CONFIRMED USING ECHOCARDIOGRAPHY. THE LOCATION OF THE PERFORATION WAS BELIEVED TO BE IN THE LEFT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED DRAINING 750 ML OF BLOOD FROM THE PERICARDIUM AND THE PT STABILIZED. THE PT HAD COMPLAINED OF CHEST DISCOMFORT THREE HOURS PRIOR TO THE NOTED EFFUSION BUT THE PHYSICIAN DOES NOT BELIEVE THIS WAS RELATED TO THE NOTED PERICARDIAL EFFUSION. THE CURRENT STATUS OF THE PT WAS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88016 3294094

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SJM SUPREME CATHETER: MODEL 401451, LOT NUMBER UNK| NAVX| ENSITE SYS