BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1980366 · Received February 3, 2011

    Report

    Report Number
    2030404-2011-00027
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - 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 FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. AS A CARDIAC PERFORATION IS AN INHERENT RISK ASSOCIATED WITH ANY CARDIAC ABLATION PROCEDURE, THE CAUSE FOR THE REPORTED EVENT IS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2011. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ISOLATION OF THE RIGHT PULMONARY VEINS, WHILE APPLYING RF AT 30 WATTS AND 40 DEGREES CELSIUS TO THE ANTERIOR PART OF THE LEFT ATRIUM, A TAMPONADE WAS NOTED. THIS WAS CONFIRMED BY A TRANSESOPHAGEAL ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PT STABILIZED. THE PHYSICIAN DECIDED TO CONTINUE THE ABLATION PROCEDURE USING THE SAME DEVICES. AFTER THE PROCEDURE, THE PT WAS TRANSFERRED TO THE ICU FOR OBSERVATION. ACCORDING TO THE PHYSICIAN, THE CATHETER WAS NOT RESPONSIBLE FOR THE TAMPONADE.

    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-CN NONE OAD ST. JUDE MEDICAL - IRVINE 88019 K20763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention