BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2081162 · Received April 14, 2011

    Report

    Report Number
    2030404-2011-00096
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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

    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. A QUALITY IMPROVEMENT PROJECT HAS BEEN INITIATED TO ADDRESS THE LUER EXTENSION TUBE SEPARATING FROM THE HANDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A (B)(4) STUDY, THE COOL PATH DUO CATHETER WAS USED TO PERFORM A PULMONARY VEIN ISOLATION PROCEDURE. AFTER 2 HOURS, IT WAS NOTED THE CATHETER TIP WAS NOT COOLING ENOUGH TO ALLOW THE STOCKERT GENERATOR TO APPLY RF DUE TO SAFETY SETTINGS ON THE GENERATOR. THE CATHETER WAS INSPECTED AND THE IRRIGATION TUBING ATTACHED TO THE PROXIMAL END OF THE HANDLE HAD BROKEN OFF, WHICH PREVENTED IRRIGATION TO THE TIP OF THE CATHETER. THE CATHETER WAS REPLACED AND THE ABLATION PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83563 3189261

    Patients

    Seq Age Sex Outcome Treatment
    1