BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2160303 · Received April 29, 2011

    Report

    Report Number
    2030404-2011-00116
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. INFORMATION IN THE COMPLAINT DESCRIPTION IS CONSISTENT WITH A DETACHED LURE EXTENSION TUBE. A QUALITY PROJECT HAS BEEN INSTITUTED THAT CONSISTS OF IMPROVEMENTS TO THE TUBING QUALITY AND MORE IMPROVEMENTS TO THE INTERNAL INSPECTION PROCESS. SJM PARTNERED WITH THE VENDOR OF THE TUBING AND DETERMINED THAT THE MATERIAL WAS NOT PROCESSED WITH THE NECESSARY CONDITIONS TO ENSURE OPTIMUM TUBING QUALITY; THE PROCESS HAS BEEN IMPROVED BY THE VENDOR. IN ORDER BETTER PREVENT POTENTIALLY DEFECTIVE TUBING FROM BEING UTILIZED DURING THE MANUFACTURING PROCESS, SJM HAS ADDITIONALLY INSTITUTED A NEW TESTING FIXTURE THAT IMPROVES OUR ABILITY TO DETECT THE NONCONFORMING TUBING.

    Description of Event or Problem · 1

    SAME CASE AS MFR. REPORT #2030404-2011-00015. IT WAS REPORTED THAT DURING A PULMONARY VEIN ABLATION PROCEDURE, THE IRRIGATION PORT DISCONNECTED FROM THE HANDLE OF THE CATHETER. WHILE USING A THERAPY COOL FLEX CATHETER, THE PHYSICIAN NOTED THAT THE IRRIGATION PORT ON THE PROXIMAL END HAD DISCONNECTED AND WAS NOT IRRIGATING THE CATHETER TIP. THE CATHETER WAS EXCHANGED FOR A COOL PATH DUO THAT DEVELOPED AN 'S' CURVE WHEN FLEXED AFTER ABOUT 45 MINUTES OF USE. THE CATHETER WAS EXCHANGED FOR A SECOND COOL PATH DUO AND WHILE ABLATING AT THE CAVOTRICUSPID ISTHMUS (CTI) FOR APPROXIMATELY 10 MINUTES A "LOUD STEAM POP" WAS HEARD. THE PATIENT REMAINED HEMODYNAMICALLY STABLE SO THE PHYSICIAN CONTINUED ABLATING FOR ANOTHER 5 MINUTES. THE PHYSICIAN STOPPED ABLATING BEFORE ACHIEVING CTI BLOCK AND ENDED THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT. THE PHYSICIAN CONSIDERED THIS A SUCCESSFUL ABLATION PROCEDURE DESPITE NOT ACHIEVING BIDIRECTIONAL BLOCK ACROSS THE CTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB CARDIAC ABLATION CATHETER PERCUTANEOUS OAD ST. JUDE MEDICAL, IRVINE 88016 3223034

    Patients

    Seq Age Sex Outcome Treatment
    1 SJM AGILIS INTRODUCER:| COOL PATH DUO: MODEL 83563, LOT 3189219| COOL PATH DUO: MODEL 88016, LOT 3223034