BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 1155576 · Received September 10, 2008

    Report

    Report Number
    3006026430-2008-00011
    Event Type
    Injury
    Date Received
    September 10, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Product Code
    DRA
    PMA / PMN Number
    K073225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU LISTS PERICARDIAL EFFUSION AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE. THE IFU STATES THE ONLY DEVICES WHICH THE ARTISAN IS CLEARED FOR USE ARE THE POLARIS-DX STEERABLE DIAGNOSTICS CATHETERS MADE BY BOSTON SCIENTIFIC CORPORATION AND THE LIVEWIRE ELECTROPHYSIOLOGY CATHETERS MADE BY ST. JUDE MEDICAL. SUMMARY OF INVESTIGATION: ARTISAN WAS EVALUATED ACCORDING TO STANDARD FAILURE ANALYSIS PROTOCOL. THE ARTISAN CATHETER PASSED ALL VISUAL INSPECTIONS WITH NO OBSERVED ISSUES. THE ARTISAN CATHETER PROGRAMMED VALUES MATCHED ORIGINAL VALUES. THE ARTISAN CATHETER WAS MANIPULATED WITH THE COOL PATH INVOLVED WITH IN THE INCIDENT STILL LOADED IN THE ARTISAN, AND NON-INSTINCTIVE DRIVING WAS OBSERVED. THE ARTISAN WAS THEN TESTED WITH A DIFFERENT MFR ABLATION CATHETER, AND WITH NO CATHETER LOADED, AND NO ISSUES WITH MANIPULATION WERE OBSERVED.

    Description of Event or Problem · 1

    AN EFFUSION WAS OBSERVED DURING A LEFT ATRIAL PROCEDURE. PERICARDIAL EFFUSION WAS NOTED WITH ULTRASOUND AND A PERICARDIOCENTESIS WAS PERFORMED. THE PT STABILIZED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. THE PT RECOVERED WITH NO FURTHER SEQUELAE. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHETER, STEERABLE DRA 04454

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R