BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2122011 · Received May 24, 2011

    Report

    Report Number
    2030404-2011-00152
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE COOL PATH CATHETER FOR AN ABLATION PROCEDURE LEAKING WAS NOTED FROM THE HANDLE OF CATHETER. THE PHYSICIAN HAD BEEN ABLATING FOR ABOUT TWO HOURS WHEN THE CATHETER WAS PULLED FROM THE LEFT ATRIUM INTO THE RIGHT ATRIUM. THE PHYSICIAN BEGAN ABLATING THE RIGHT SIDED ISTHMUS REGION WHEN HE NOTED SOME LEAKING COMING FROM THE HANDLE OF THE CATHETER. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT. THE PATIENT LEFT THE ROOM STABLE AND COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 84309 3287478

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR