BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    MDR report key: 2000718 · Received February 16, 2011

    Report

    Report Number
    2030404-2011-00045
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. AS CARDIAC TAMPONADE IS AN INHERENT RISK ASSOCIATED WITH CARDIAC ABLATION PROCEDURES, THE CAUSE FOR THE REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT DEVELOPED A CARDIAC TAMPONADE. THE OPTIMA CATHETER AND THE COOL PATH ABLATION CATHETER WERE DISCONNECTED FROM THE EQUIPMENT WHEN THE PHYSICIAN NOTICED THE PATIENT WAS NOT FEELING WELL. AN ECHOCARDIOGRAM CONFIRMED CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB NONE OAD ST. JUDE MEDICAL, IRVINE 83503 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SJM OPTIMA CATHETER| MEDTRONIC TRANSSEPTAL SHEATH