BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY 1100 SERIES DIAGNOSTIC CATHETER

    MDR report key: 529487 · Received June 11, 2004

    Report

    Report Number
    2030404-2004-00001
    Event Type
    Injury
    Date Received
    June 11, 2004
    Date of Event
    May 11, 2004
    Report Date
    June 10, 2004
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT INSERTION OF CATHETER AS A PRE-REQUISITE FOR A RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION. THREE DIFFERENT DIAGNOSTIC/MAPPING CATHETERS WERE INSERTED. AN INQUIRY CATHETER (IRVINE BIOMEDICAL) WAS INSERTED INTO THE LEFT FEMORAL VEIN AND POSITIONED IN THE CORONARY SINUS. AN ICE - INTRACARDIAC ECHOCARDIOGRAM CATHETER (BOSTON SCIENTIFIC) WAS INSERTED INTO THE RIGHT FEMORAL VEIN AND POSITIONED NEAR THE RIGHT ATRIAL SEPTUM FOR VIEWING INTO THE LEFT ATRIUM. A TRANSSEPTAL PROCEDURE WAS PERFORMED AND A BIOSENSE WEBSTER CATHTER WAS INSERTED INTO THE LEFT ATRIUM. MAPPING OF THE PULMONARY VEINS WAS PERFORMED USING AN ESI 3-D NAVIGATION SYSTEM. AT THIS TIME, THE PT BECAME HYPOTENSIVE WITH DECREASING BLOOD PRESSURES. THE PT WAS INTUBATED AND STARTED ON A DOPAMINE INFUSION. A PERICARDIALCENTESIS WAS PERFORMED WITHDRAWING ABOUT 350CC OF FLUID FROM THE HEART. THE PT STABILIZED AND WAS TRANSFERRED TO THE INTENVSIVE CARE UNIT. THE PT REMAINED INTUBATED AS THERE WAS CONCERN THAT THE PT HAD ASPIRATED DURING THE INTUBATION. NO ABLATION WAS PERFORMED. THE PHYSICIAN'S MEDICAL OPINION WAS THAT THE TAMPONADE OCCURRED DUE TO A TEAR IN THE CORONARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY 1100 SERIES DIAGNOSTIC CATHETER DIAGNOSTIC EP CATHETER DRF IRVINE BIOMEDICAL, INC. (IBI) 81202 28815

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention BOSTON SCIENTIFIC ULTRA ICE CATHETER,| BIOSENSE WEBSTER CATHETER (MODEL UNK).