BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 3299454 · Received August 15, 2013

    Report

    Report Number
    2134243-2013-00008
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    July 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI WAS REQUESTED BY ACIST TO BE RETURNED TO ACIST FOR TESTING PER ACIST'S STANDARD PROCEDURE, THE USER FACILITY ELECTED NOT TO RETURN THE INJECTION SYSTEM TO ACIST FOR TESTING. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSPITAL; THEREFORE, NO ANALYSIS COULD BE MADE OF THESE ITEMS. ACIST'S MEDICAL ADVISORY BOARD REVIEWED THE INFO AND A COPY OF THE CINE-ANGIOGRAM PROVIDED BY THE HOSPITAL OF THE EVENT: THE PT HAD CHEST PAIN AND ST ELEVATION, BUT WAS OTHERWISE STABLE. THE ANGIOGRAM SHOWS ON RUN 5 OCCLUSION OF THE FIRST OBTUSE MARGINAL (OM1), FIRST DIAGONAL (D1) AND POSSIBLY THE LEFT ANTERIOR DESCENDING (LAD) (WHICH HAS A GRAFT) WITH PERSISTENCE OF CONTRAST AFTER INJECTION. THIS IS COMPATIBLE WITH AN AIR INJECTION JUST BEFORE THE ANGIOGRAPHIC INJECTION. THE CAUSE IS UNKNOWN, BASED ON THE CLINICAL INFO AND ANGIOGRAM. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATION'S IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM. THE ACIST CONTRAST INJECTION SYSTEM IS EQUIPPED WITH AN AIR COLUMN DETECT SENSOR. THE AIR COLUMN DETECT SENSOR SENSES AIR IN THE PROXIMAL END OF THE HIGH-PRESSURE (INJECTION) TUBING. IF AIR IS DETECTED IN THE TUBING, ALL FLUID DELIVERY FUNCTIONS ARE DISABLED. PER THE ACIST CVI USERS MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. THERE IS NO DEFINITE CONCLUSION AS TO THE CAUSE OF THIS EVENT. AGAIN, THE USER FACILITY ELECTED TO NOT RETURN THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, TO ACIST FOR TESTING, PER ACIST'S REQUESTS. THE USER FACILITY HAS CONTINUED TO USE THE INJECTION SYSTEM SINCE THE EVENT. THE ACIST CLINICAL VASCULAR SPECIALIST HAD A FOLLOW-UP APPLICATIONS VISIT WITH THE USER FACILITY ON (B)(4) AND WILL SCHEDULE AN ADDITIONAL VISIT WITHIN THE NEXT TWO WEEKS. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: PT RIGHT HEART CATHETERIZATION AND LEFT HEART CATHETERIZATION PERFORMED. AFTER THE LEFT VENTRICULAR (LV) GRAM, THE CATHETERIZATION LAB STAFF NOTED THE PT WAS EXPERIENCING ST ELEVATION AND CHEST PAIN. MORPHINE AND FENTANYL WERE ADMINISTERED ALONG WITH 2 LITERS OF OXYGEN VIA NASAL CANNULA. CHEST PAIN SUBSIDED ON ITS OWN. EJECTION FRACTION (EF) NOTED BY THE PHYSICIAN AT 15%. THE CATHETERIZATION LAB STAFF AND MANAGEMENT WERE UNSURE IF AIR HAD BEEN INJECTED INTO THE PT AS THERE WERE NO IMAGES TAKEN AFTER THE PT COMPLAINED OF CHEST PAIN; THEREFORE, THERE WAS NO CONFIRMATION OF THE PRESENCE OF AIR. THE CAUSE OF THE PT'S SOURCE OF PAIN IS UNKNOWN; PAIN MAY HAVE BEEN DUE TO SPASM, CLOT, OR AIR. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393365 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CVI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| O| R FENTANYL| VERSED (MIDAZOLAM HYDROCHLORIDE)| MORPHINE| CORDIS 5FR JR4 DIAGNOSTIC| EDWARDS LIFE 7FR SWAN-GANZ W/O HEPARIN| CORDIA 5FR PIGTAIL DIAGNOSTIC| CORDIS 5FR JL4 DIAGNOSTIC