BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 841398 · Received April 18, 2007

    Report

    Report Number
    2134243-2007-00001
    Event Type
    Injury
    Date Received
    April 18, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 18, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: THE ANGIOGRAPHIC INJECTOR WAS TAKEN OUT OF SERVICE IN 2007 AND RETURNED TO ACIST MEDICAL SYSTEMS ON MARCH 26, 2007. THE ANGIOGRAPHIC INJECTOR WAS TESTED AND MET ALL PRE-ESTABLISHED SPECIFICATIONS. DISPOSABLE KITS USED DURING THE PROCEDURE WERE RETURNED TO ACIST MEDICAL SYSTEMS AND TESTED UNDER SIMULATED USE AND PASSED FUNCTIONAL TESTING. THE CINEANGIOGRAM FROM THE PROCEDURE WAS REVIEWED BY ACIST'S MEDICAL ADVISORY. THE CINEANGIOGRAM INDICATED THAT AN AIR INJECTION OCCURRED ON THE FIRST INJECTION, RESULTING IN CHEST PAIN AND ECG CHANGES. THE FIRST RUN OF THE ANGIOGRAM SHOWS WHAT APPEARS TO BE AN AIR EMBOLISM OCCLUDING THE DISTAL PORTION OF THE LAD ARTERY. THIS OCCLUSION IS GONE ON THE REMAINDER OF THE LEFT CORONARY INJECTIONS. AN LV ANGIOGRAM AT THE END OF THE PROCEDURE SHOWS THAT THE ANTERIOR WALL FED BY THE LAD HAD NORMAL FUNCTION. THERE WAS NO PERMANENT INJURY TO THE PATIENT. BASED ON ACIST'S ANALYSIS , THE SYSTEM WAS DETERMINED TO BE OPERATING TO SPECIFICATIONS. BASED ON DATA FROM THE ANALYSIS, THE EVENT IS NOT CONSIDERED TO BE DEVICE-RELATED, HOWEVER NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT WHILE PERFORMING A LEFT HEART CATHETERIZATION USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTOR, A PATIENT HAD CHEST PAIN FOR A DURATION OF 20 MINUTES, ST SEGMENT ELEVATION AND BRADYCARDIA. THE USER FACILITY WAS UNSURE IF THE CAUSE WAS A BLOOD CLOT OR IF AN AIR INJECTION HAD OCCURRED. THE PATIENT WAS ADMITTED TO THE CCU FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization