BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER

    MDR report key: 2144477 · Received June 22, 2011

    Report

    Report Number
    3003610571-2011-00001
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DQO
    PMA / PMN Number
    K012749
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN/USER COMMENT: VENTRICULAR TACHYCARDIA IS FREQUENTLY PROVOKED DURING RETROGRADE LEFT VENTRICULAR CATHETER MANIPULATION. USUALLY IT IS A SELF-TERMINATING ARRHYTHMIA, BUT MAY ALSO BE SUSTAINED, PARTICULARLY IN PATIENTS WITH LEFT VENTRICULAR DISEASE. CARDIAC CATHETERIZATION LABORATORY PRACTICES PERMIT THE PROMPT RECOGNITION AND TREATMENT OF ARRHYTHMIAS. INFORMED CONSENT FORMS FOR CATHETERIZATION ADVISE PATIENTS OF THE RISK OF ARRHYTHMIAS. CONCLUSIONS: THERE IS NOTHING THAT CAN BE SEEN ON THIS CATHETER THAT WOULD INDICATE THAT IT DOES NOT CONFORM TO OUR SPECIFICATIONS. THERE ARE NO IRREGULARITIES OR OTHER FEATURES THAT WOULD SEEM LIKELY TO CAUSE ANY INJURY OR DAMAGE TO PATIENT ANATOMY.

    Description of Event or Problem · 1

    A SERIOUS ADVERSE EVENT OCCURRED POSSIBLY RELATED TO THE MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 00895. THE PATIENT HAD ISCHEMIC CARDIOMYOPATHY, VENTRICULAR REMODELING SURGERY, AND A FUNCTIONING AUTOMATIC INTERNAL DEFIBRILLATOR (WHICH WAS TURNED OFF FOR THE PROCEDURE) AND ENROLLED IN AN INVESTIGATIONAL CLINICAL TRIAL FOR STEM CELL THERAPY. LEFT HEART CATHETERIZATION WITH THE MORPH GUIDING CATHETER WAS ACCOMPLISHED OVER A GUIDEWIRE WITHOUT INCIDENT. THE INVESTIGATION HELICAL INFUSION CATHETER WAS RETRACTED INSIDE THE MORPH GUIDE, WHICH WAS NAVIGATED TO THE MID-ANTERIOR SEPTUM. WHEN THE TIP OF THE MORPH GUIDE TOUCHED THE ENDOCARDIUM OF THIS SEGMENT, THE PATIENT IMMEDIATELY CONVERTED TO RAPID PULSELESS MONOMORPHIC VENTRICULAR TACHYCARDIA. THE ARRHYTHMIA WAS SUSTAINED DESPITE WITHDRAWAL OF THE CATHETER FROM THE LEFT VENTRICLE INTO THE AORTA. THE PHYSICIAN TREATED THIS WITH A SINGLE EXTERNAL COUNTERSHOCK, RESTORING SINUS RHYTHM. THE REMAINDER OF THE PROCEDURE WAS COMPLETED AND WAS UNEVENTFUL. A FEW HOURS AFTER THE PROCEDURE, THE PATIENT DESCRIBED VAGUE RECALL OF THE CARDIOVERSION EPISODE; HE WAS COMFORTABLE IN HIS HOSPITAL ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER GUIDE CATHETER DQO BIOCARDIA, INC. 00895 00850

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R BIOCARDIA HELICAL INFUSION CATHETER: MODEL 00953| GUIDEWIRE, MAKER AND MODEL UNKNOWN