BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 2455466 · Received February 10, 2012

    Report

    Report Number
    2134243-2012-00005
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    December 12, 2011
    Report Date
    February 10, 2012
    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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K NUMBER: K010390. THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST ON (B)(4) 2012 FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY; THEREFORE, NO ANALYSIS COULD BE MADE OF THOSE ITEMS. ACIST'S MEDICAL ADVISORY BOARD MEMBERS REVIEWED THE INFO AND A COPY OF THE CINE-ANGIOGRAM PROVIDED BY THE HOSPITAL OF THE EVENT. THE ANGIOGRAM SHOWS TWO AIR BUBBLES ABOUT 3 - 3.5 MM IN DIAMETER INJECTED INTO THE LEFT CIRCUMFLEX ON THE FIRST INJECTION, WHICH UTILIZED A GUIDING CATHETER. BLOOD FLOW APPEARED NORMAL ON THE NEXT INJECTION. THERE WERE NO CLINICAL SYMPTOMS REPORTED. THE LIKELY SOURCE IS AN INCOMPLETE SET-UP PURGE OF AIR IN A "Y" CONNECTOR, BUT THE SOURCE CANNOT BE IDENTIFIED WITH CERTAINTY. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE RESULTS OF THE INJECTOR TESTING. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED ON (B)(4) 2012. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS 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. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED DURING A LEFT HEART CATHETERIZATION, AIR WAS INJECTED INTO A PT. THERE WERE NO CLINICAL SYMPTOMS REPORTED. THE PT'S CONDITION WAS MONITORED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization