BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL PATH CATHETER

    MDR report key: 1852386 · Received September 29, 2010

    Report

    Report Number
    2030404-2010-00151
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PERICARDIAL EFFUSION REMAINS UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER ISOLATING THE LEFT PULMONARY VEINS, THE PT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER NONE OAD ST. JUDE MEDICAL, IRVINE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INQUIRY OPTIMA ELECTROPHYSIOLOGY CATHETER