BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2153093 · Received June 17, 2011

    Report

    Report Number
    2030404-2011-00185
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY THE MFR - VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE LUER EXTENSION TUBE BROKE AT THE HANDLE EDGE AND SEPARATED FROM THE HANDLE. FURTHER FUNCTIONAL TESTING OF THE CATHETER COULD NOT BE PERFORMED DUE TO THIS SEPARATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH SUPPLIER QUALITY. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO INVESTIGATE THE ISSUE AND IMPROVE THE PROCESS. AS A RESULT, IMPROVEMENTS TO THE TUBING QUALITY AND IMPROVEMENTS TO THE INTERNAL INSPECTION PROCESS HAVE BEEN INSTITUTED. 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 TO 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

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE COOL FLEX CATHETER IRRIGATION PORT DISCONNECTED FROM THE PROXIMAL END OF THE HANDLE. THE PHYSICIAN USED THE CATHETER TO CHECK THE CARDIAC SIGNALS AND DELIVER THERAPY TO ISOLATE THE LEFT PULMONARY VEINS. THE COOL FLEX CATHETER WAS THEN MOVED FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM. THE PHYSICIAN BEGAN TO DELIVER THERAPY TO THE RIGHT ATRIAL ISTHMUS WHEN THE GENERATOR REPORTED ABNORMAL ENERGY AND TEMPERATURE READINGS. THE PHYSICIAN EXAMINED THE COOL FLEX CATHETER, NOTING THE IRRIGATION PORT DISCONNECTED FROM THE PROXIMAL END OF THE HANDLE. THE PHYSICIAN REMOVED THE COOL FLEX CATHETER FROM THE PT AND UTILIZED A BIOTRONIK ABLATION CATHETER TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    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 PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88016 3294097

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR