BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER

    MDR report key: 2627083 · Received June 21, 2012

    Report

    Report Number
    2030404-2012-00178
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 30, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ST. JUDE MEDICAL ¿ IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K042775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF EVALUATING THE DEVICE. UPON COMPLETION OF THE EVAL OF THE DEVICE A FOLLOW UP MED WATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REDO PAROXYSMAL LEFT ATRIAL FIBRILLATION PROCEDURE, CATHETER REMOVAL DIFFICULTIES OCCURRED. AN 8.5F SWARTZ SLO INTRODUCER AND INQUIRY AFOCUSII CATHETER WERE ADVANCED INTO THE LEFT ATRIA. THE PHYSICIAN CREATED GEOMETRY OF FOUR PULMONARY VEINS AND SUCCESSFULLY ABLATED THE LEFT SUPERIOR, LEFT INFERIOR AND RIGHT SUPERIOR VEINS. WHILE ABLATING THE RIGHT INFERIOR VEIN, THE PHYSICIAN WAS UNABLE TO STRAIGHTEN OR MANIPULATE THE CATHETER OUT OF THE RIGHT DEFLECTED POSITION. THE PHYSICIAN ATTEMPTED TO REMOVE THE INQUIRY AFOCUSII CATHETER FROM RIGHT INFERIOR VEIN; HOWEVER, THIS WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE INQUIRY AFOCUS II CATHETER INTO THE SWARTZ INTRODUCER INTO THE RIGHT ATRIA AND WAS FINALLY ABLE TO SLIGHTLY WITHDRAW THE INQUIRY AFOCUSII CATHETER INTO THE SWARTZ INTRODUCER AND REMOVE THE INQUIRY AFOCUSII OUTSIDE OF THE PT. A NEW CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL ¿ IRVINE 87008 K29938

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR LOT# UNK| 8.5F SCHWARTZ SLO INTRODUCER: (PRODUCT ID#: 407451