BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVEWIRE TC ABLATION CATH, UNIV. TEMP, 7F QUAD, XLS

    MDR report key: 2142220 · Received May 26, 2011

    Report

    Report Number
    3005188751-2011-00057
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    September 22, 2010
    Report Date
    May 3, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - ONE 7F LIVEWIRE TC CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED CHARRING ON THE TIP ELECTRODE. FUNCTIONAL TESTING CONFIRMED THE DEVICE PRODUCED THE CORRECT SHAPE WHEN ACTUATING THE STEERING MECHANISM. ELECTRICAL TESTING REVEALED NO OPEN OR SHORT CIRCUITS. THE TEMPERATURE RESPONSE OF THE THERMOCOUPLE AND THERMISTOR WERE WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE CATHETER TO PERFORM ABLATION, A "POP" WAS NOTED AFTER THE FOURTH RF ABLATION APPLICATION. ABLATION WAS PERFORMED FOR 46 SECONDS WITH THE FOLLOWING PARAMETERS: TEMPERATURE : 50-60 DEGREE C, POWER: 50 TO 70 W (MAX 67W), IMPEDANCE 100 OHMS. CARBONIZATION WAS NOTED ON THE TIP OF THE ABLATION CATHETER. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE TC ABLATION CATH, UNIV. TEMP, 7F QUAD, XLS LIVEWIRE TC, 7F, XLS DRF ST. JUDE MEDICAL, AF DIVISION 402196 3150571

    Patients

    Seq Age Sex Outcome Treatment
    1