BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F IRRIGATED ABLATION CATHETER

    MDR report key: 1934269 · Received November 24, 2010

    Report

    Report Number
    2030404-2010-00240
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A F/U REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MFR: 11/24/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HANDLE LEAK DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F IRRIGATED ABLATION CATHETER NONE OAD ST JUDE MEDICAL, IRVINE 83352 K28201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK