BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1913945 · Received November 30, 2010

    Report

    Report Number
    2030404-2010-00244
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 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 CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED TAMPONADE IS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUCCESSFUL RIGHT VENTRICULAR OUTFLOW TRACT ABLATION PROCEDURE, THE PT DEVELOPED A CARDIAC TAMPONADE. THE PT WAS STABLE THROUGHOUT THE ENTIRE PROCEDURE UP UNTIL THE LAST ABLATION WAS PERFORMED. THE DURATION OF THE LAST ABLATION APPLICATION WAS APPROXIMATELY 280 SECONDS. THE PHYSICIAN WAS UNCERTAIN OF THE CAUSE FOR THE TAMPONADE BUT SUGGESTS IT MAY BE DUE TO THE LONG DURATION OF THE LAST ABLATION APPLICATION. A PERICARDIOCENTESIS WAS PERFORMED, WHICH RESOLVED THE EFFUSION AND THE PT IS REPORTEDLY 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 NONE OAD ST. JUDE MEDICAL, IRVINE 83562 K31594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention