BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1895404 · Received November 4, 2010

    Report

    Report Number
    2030404-2010-00216
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    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

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOWUP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER 1 HOUR OF ABLATION WITH THE COOL PATH DUO CATHETER, THE TEMPERATURE READING ON THE RF GENERATOR APPEARED TO BE 75 DEGREES CELSIUS. THE PHYSICIAN EXTRACTED THE CP DUO FOR INSPECTION AND NOTICED THAT SALINE VOLUME FLOW FROM THE TIP WAS LOWER THAN EXPECTED. THE PHYSICIAN CHANGED TO A NON-IRRIGATED THERAPY ABLATION CATHETER, AND AFTER ABOUT 6 MINUTES OF ABLATION, IT WAS NOTED THE PATIENT HAD DEVELOPED A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS TO RESOLVE THE TAMPONADE WITH NO CONSEQUENCES TO THE PATIENT. THE PHYSICIAN DID NOT RELATE THE TAMPONADE TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83563 K19912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention