BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTRACK MICROCATHETER

    MDR report key: 5150029 · Received October 14, 2015

    Report

    Report Number
    9710452-2015-00018
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DQX
    PMA / PMN Number
    K014075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE. PROCEDURAL ERROR MAY HAVE CONTRIBUTED TO THE REPORTED COMPLICATION. THE ARTICLE STATES, "THIS LIKELY RESULTED FROM THE MICROCATHETER ABUTTING THE RV FREE WALL AS THE GUIDEWIRE WAS PASSED AND SHOULD BE AN AVOIDABLE COMPLICATION."

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: LIN, C. H., HUDDLESTON, C., & BALZER, D. T. (2013). TRANSCATHETER VENTRICULAR SEPTAL DEFECT (VSD) CREATION FOR RESTRICTIVE VSD IN DOUBLE-OUTLET RIGHT VENTRICLE. PEDIATRIC CARDIOLOGY, 34(3), 743-747. AS PER THE ARTICLE, "THE COAXIAL MICROCATHETER THEN WAS ADVANCED OVER THE BAYLIS WIRE INTO THE RV. THE BAYLIS WIRE WAS REMOVED, AND INITIALLY, A 0.018-IN. TERUMO GLIDEWIRE (TERUMO CORP., (B)(6)) WAS ADVANCED INTO THE RV. THE WIRE WAS NOTED TO CROSS THE FREE WALL OF THE RV AND ENTER THE PERICARDIAL SPACE. A SMALL PERICARDIAL EFFUSION ASSOCIATED WITH HYPOTENSION AND VENTRICULAR DYSFUNCTION WAS NOTED. THE WIRE WAS REMOVED, AND EMERGENT PERICARDIOCENTESIS WAS PERFORMED, WITH 12 ML OF BLOOD REMOVED THROUGH A 5-FR PIGTAIL CATHETER PLACED IN THE PERICARDIAL SPACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680371 PROTRACK MICROCATHETER COAXIAL CATHETER DQX BAYLIS MEDICAL COMPANY INC. CIC 38-145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention