BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1848998 · Received September 21, 2010

    Report

    Report Number
    2030404-2010-00143
    Event Type
    Other
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER IS CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THERE WAS NO ISSUE RELATED TO COMPLAINT DURING MFG PROCESS. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. DATE REPORT SUBMITTED TO FDA BY MFR: 09/21/2010. DATE THE INITIAL RPTR PROVIDED THE INFO TO THE MFR: (B)(4)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING ABLATION DURING A PVI PROCEDURE. THE PHYSICIAN NOTICED SALINE LEAKING FROM THE HANDLE OF THIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-XL- TE4BE1AB NONE OAD ST. JUDE MEDICAL 83564 K27284

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK