BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 2010441 · Received March 1, 2011

    Report

    Report Number
    2030404-2011-00057
    Event Type
    Death
    Date Received
    March 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE EVENT DATE IS (B)(6) 2010. THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNK. THE CAUSE FOR THE REPORTED CARDIAC TAMPONADE AND SUBSEQUENT DEATH IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT WITH PERSISTENT ATRIAL FIBRILLATION UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE. THE PT WAS UNDER GENERAL ANESTHESIA AND HAD TWO TRANSSEPTAL PUNCTURES PERFORMED. AN SLO INTRODUCER AND AN AGILIS NXT INTRODUCER WERE USED IN CONJUNCTION WITH A COOL FLEX ABLATION CATHETER. THE PT UNDERWENT PULMONARY VEIN WIDE ENCIRCLEMENT AND A ROOF LINE. A MITRAL ISTHMUS LINE WAS ATTEMPTED, AND MITRAL ISTHMUS BLOCK PROVED DIFFICULT TO ACHIEVE. THE PHYSICIAN DECIDED TO USE 50W WITH A MAXIMUM TEMP OF 48 DEGREES CELSIUS WHICH IS OUTSIDE THE RECOMMENDED SETTINGS NOTED IN THE IFU FOR THIS PRODUCT OF 50W WITH A MAXIMUM TEMP OF 45 DEGREES. DURING THE MITRAL ISTHMUS LINE, THE PATIENT'S PRESSURE DROPPED SEVERELY, AND AN ECHOCARDIOGRAM SHOWED FLUID IN THE PERICARDIAL SPACE. THE ABLATION WAS HALTED AND PERICARDIOCENTESIS WAS ATTEMPTED. THE SURGEONS HAD TO BE CALLED TO ASSIST AND THE PT WAS EVENTUALLY TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR. THE PHYSICIAN STATES HE WAS AGGRESSIVE IN TRYING TO ACHIEVE THE ISTHMUS BLOCK AND DOES NOT IMPLICATE THE COOL FLEX CATHETER AS BEING THE CAUSE FOR THE CARDIAC TAMPONADE. POST PROCEDURE, THE PT HAD RECENTLY DIED OF PNEUMONIA, WHICH IS BELIEVED TO BE DIRECTLY RELATED TO THE TAMPONADE AND SUBSEQUENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-LX-TE4BE1EB NONE OAD ST. JUDE MEDICAL, IRVINE 88017 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SL0 INTRODUCER| AGILIS NXT INTRODUCER