BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3040348 · Received June 10, 2008

    Report

    Report Number
    2182269-2008-00262
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    April 11, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LPB
    PMA / PMN Number
    P960016
    Removal / Correction Number
    2182269-06/09/08-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL CONFIRMED ON (B)(4), 2008 DURING DEVICE EVALUATION THAT THE PRODUCT SHIPPED WAS LABELED AS AN 8 MM ABLATION CATHETER, BUT THE DEVICE/CATHETER HAD THE COMPONENTS OF A 4 MM ABLATION CATHETER. RF GENERATORS HAVE TEMPERATURE LIMITS, TEMPERATURE CONTROLS, AND HIGH IMPEDANCE SHUTDOWN FEATURES. THE MISUSE OR MALFUNCTION OF ANY OF THESE FEATURES MAY LEAD TO HIGH TEMPERATURE RESULTING IN COAGULUM FORMATION. THE INSTRUCTIONS FOR USE (IFU) FOR THE CATHETERS STATES "A SUDDEN IMPEDANCE RISE DURING AN ABLATION PROCEDURE IS TYPICALLY INDICATIVE OF LOSS OF TISSUE CONTACT AND/OR COAGULUM BUILDUP AT THE DISTAL TIP. REMOVE THE CATHETER FROM THE PT AND CLEAN TIP BEFORE PROCEEDING". VOLUNTARY FIELD ACTION NUMBER: 2182269-06/09/08-001-R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERFERENCE WAS NOTED ON THE DISTAL ELECTRODE BEFORE RF DELIVERY. THERE WAS NO PT INJURY REPORTED.

    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 LPB ST. JUDE MEDICAL 402196 2056960

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK