BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F, 1304-CP-7-25-M-AB (USA)

    MDR report key: 1961662 · Received December 28, 2010

    Report

    Report Number
    2030404-2010-00285
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING OF THE CATHETER REVEALED THE DEVICE PASSED PRESSURE DROP TESTING, ABLATION SIMULATION TESTING AND THE RATE TEST. WATER WAS PUSHED THROUGH THE CATHETER LUER TOWARD THE TIP USING A SYRINGE AND DID NOT COME OUT THROUGH THE CATHETER HANDLE BUT PASSED THROUGH THE TIP AS DESIGNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/28/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HANDLE LEAK AT THE PROXIMAL END OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-M-AB (USA) NONE OAD ST. JUDE MEDICAL, IRVINE 84308 K25238

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR