BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3240673 · Received July 22, 2013

    Report

    Report Number
    2029046-2013-00093
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WILL NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: CARTO 3 SYSTEM US CATALOG #: FG540000J, SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) AND VENTRICULAR TACHYCARDIA (VT) CASE, A CARDIAC TAMPONADE OCCURRED. SOUND MAP WAS CREATED AT THE RIGHT VENTRICLE, LEFT VENTRICLE AND AORTA, AND IT WAS MERGED WITH COMPUTED TOMOGRAPHY (CT). THE CATHETER WAS PLACED INSIDE THE CARDIAC CAVITY. SUSTAIN VT WAS INDUCED AT HR200 BPM. THE BLOOD PRESSURE WAS STABLE AROUND 200 AND ACTIVATION MAP WAS CREATED. EARLIEST EXCITATION WAS JUST RIGHT ABOVE THE PULMONARY VALVE AT THE SEPTUM SIDE. THE PHYSICIAN ABLATED THE AREA AT 30 W. TACHYCARDIA CYCLE LENGTH (TCL) WAS DELAYED AROUND 20 MS, BUT SINCE TACHYCARDIA WAS NOT STOPPED, THE ABLATION WAS PURSUED AT 35W AND THEN 40W. WHEN 7TH ABLATION WAS DELIVERED, AFTER VT WAS STOPPED, SUDDENLY THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PATIENT COMPLAINED ABOUT PAIN AND MOVED STRONGLY. RAVONAL WAS ADMINISTRATED. BECAUSE VT REOCCURRED SPONTANEOUSLY, DIRECT CURRENT (DC) WAS PERFORMED TWICE. VT STOPPED BY ADMINISTRATION OF ANCARON. ECHO WAS CONDUCTED AND PERICARDIAL EFFUSION WAS OBSERVED. PERICARDIOCENTESIS WAS PERFORMED AND 400 CC OF BLOOD WAS DRAINED. THE CASE WAS ABANDONED AND THE PATIENT WAS TRANSFERRED TO ICU. AFTER THAT, THE PATIENT WAS IN STABLE CONDITION. PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE EVENT STATED THAT IT MIGHT BE CAUSED BY THE ABLATION PROCEDURE DUE TO THE CONTACT BETWEEN THE TIP OF THE CATHETER AND THE CARDIAC WALL THAT WAS PRESSED TOO MUCH. THE OUTCOME OF THE EVENT WAS FULLY RECOVERED AND STABLE. THERE WAS NO POP OBSERVED. THE PROCEDURE WAS COMPLETED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341888 EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1292-05-S UNKNOWN_D-1292-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R