BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

    MDR report key: 2860185 · Received November 21, 2012

    Report

    Report Number
    2030404-2012-00292
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATE THE DEVICE INVOLVED IN THIS INCIDENT AS THE COMPONENTS OF THE DEVICE HAVE NOT BEEN RETURNED FOR ANALYSIS. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE BEGINNING OF AN ABLATION PROCEDURE, USING A COOL FLEX ABLATION CATHETER, THE IRRIGATION PORT DETACHED FROM THE CATHETER HANDLE. THE PHYSICIAN PULLED A COOL FLEX CATHETER OUT OF THE BOX AND FLUSHED IT. THE CATHETER WAS ADVANCED INTO THE SHEATH AND AN OCCLUSION ERROR APPEARED ON THE COOL POINT PUMP. THE PHYSICIAN NOTED THAT THE IRRIGATION PORT WAS BROKEN AT THE HANDLE, THOUGH IT WAS NOT COMPLETELY DETACHED. THIS COOL FLEX CATHETER WAS EXCHANGED FOR ANOTHER COOL FLEX CATHETER, WHICH WAS FLUSHED PRIOR TO INSERTION. WHEN THIS CATHETER WAS ADVANCED INTO THE PATIENT, THE PHYSICIAN NOTED SALINE LEAKING FROM THE CATHETER HANDLE AND THAT THE IRRIGATION PORT WAS COMPLETELY DETACHED. THE PHYSICIAN EXCHANGED THIS CATHETER FOR A COOL PATH DUO ABLATION CATHETER TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088015 3612832

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 361832| COOL FLEX ABLATION CATHETER,MODEL A088015,| COOL PATH DUO ABLATION CATHETER| ARRAY CATHETER