BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB

    MDR report key: 2153238 · Received May 27, 2011

    Report

    Report Number
    2030404-2011-00159
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. 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

    IT WAS REPORTED THAT DURING A PULMONARY VEIN ABLATION PROCEDURE, THE PT DEVELOPED A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED ISOLATION OF THE RIGHT AND LEFT SIDED PULMONARY VEINS USING A COOL PATH CATHETER AND AFTER COMPLETING ISOLATION OF THE LEFT SIDED VEINS THE PTS BLOOD PRESSURE DROPPED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION. THE PHYSICIAN STOPPED THE PROCEDURE, REMOVED THE CATHETERS FROM THE HEART AND PERFORMED A PERICARDIOCENTESIS. THE PT WAS THEN TAKEN TO EMERGENCY SURGERY AND A HOLE IN THE LEFT SUPERIOR PULMONARY VEIN WAS CLOSED. THE PT IS RECOVERING AND IS WELL AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83562 3303875.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention INQUIRY CATHETER (MODEL AND LOT UNK)| TRANSSEPTAL NEEDLE (MODEL AND LOT UNK)| OPTIMA CATHETER (MODEL AND LOT UNK)| 2 AGILIS INTRODUCERS (LOT 3277408)