BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1914198 · Received December 1, 2010

    Report

    Report Number
    2030404-2010-00252
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING OF THE RETURNED CATHETER CONFIRMED THE CATHETER PASSED ALL TESTING. THE TIP OF THE CATHETER WAS INSPECTED UNDER THE MICROSCOPE WHICH REVEALED NO ANOMALIES. THE CAUSE FOR THE REPORTED EVENT IS UNK. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PULMONARY VEIN ABLATION PROCEDURE, WHILE ABLATING AROUND THE RIGHT SIDED PULMONARY VEINS, THE PT DEVELOPED A PERICARDIAL EFFUSION. NO DEVICE PROBLEMS OR DEFECTS WERE NOTED, BUT IT WAS REPORTED THE PERICARDIAL EFFUSION DEVELOPED BECAUSE, THE PHYSICIAN APPLIED TOO MUCH PRESSURE AND SPENT TOO MUCH TIME ABLATING WITHIN ONE AREA IN THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PT STABILIZED WITH NO FURTHER CONSEQUENCES.

    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 83562 3175311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention