BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH DUO 7F CATHETER 1302-CP2-7-2-NS-TE4BE1

    MDR report key: 2903493 · Received January 3, 2013

    Report

    Report Number
    2030404-2012-00312
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO SJM FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THE REPORTED PERICARDIAL EFFUSION IS 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

    A PERICARDIAL EFFUSION OCCURRED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. THE PHYSICIAN PERFORMED A LEFT ATRIAL ROOF LINE ABLATION WITH A COOL PATH DUO ABLATION CATHETER AND NOTED A PERICARDIAL EFFUSION FOR WHICH THE PT EXHIBITED NO SYMPTOMS. A PERICARDIOCENTESIS WAS PERFORMED AND THE ABLATION PROCEDURE WAS ABORTED AT THAT TIME AND THE PT WAS DOING WELL. THE PHYSICIAN ATTRIBUTES THE EFFUSION TO ABLATION ON THE LEFT ATRIAL ROOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321 COOL PATH DUO 7F CATHETER 1302-CP2-7-2-NS-TE4BE1 CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) 88008 3803906

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention INQUIRY STEERABLE CATHETER: MODEL 81104, LOT UNK| REFLEXION SPIRAL CATHETER: MODEL 402893, LOT UNK| ARTISAN HANSEN SHEATH: MODEL 04453| SWARTZ BRAIDED INTRODUCER: MODEL 407449, LOT UNK