BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 16456363 · Received February 28, 2023

    Report

    Report Number
    2134243-2023-00003
    Event Type
    Death
    Date Received
    February 28, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER 30014306, WAS RETURNED TO ACIST MEDICAL SYSTEMS FOR EVALUATION ON (B)(6) 2023. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE NOT KNOWN.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS EVALUATED (B)(6), 2023. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR USE OF THE DEVICE. PER THE ACIST CVI USER'S 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 PATIENT 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. THE CINE-ANGIOGRAMS HAVE NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE CINE-ANGIOGRAMS HAVE BEEN EVALUATED.

    Additional Manufacturer Narrative · 0

    SECTION D4: UDI ENTERED IN THIS FIELD IS THE INJECTOR HEAD UDI WHICH IS PART OF THIS SYSTEM. THE CINE-ANGIOGRAMS WERE RECEIVED AND THE ACIST MEDICAL ADVISOR'S EVALUATION SUMMARY IS AS FOLLOWS: THE INFORMATION PROVIDED BY THE USER FACILITY DESCRIBES APPARENT USER ERROR AT THE TIME OF THE SETUP OF THE CONSUMABLE KITS AND INCOMPLETE EVACUATION OF AIR. THE PROCEDURE WAS INITIATED AND THE PATIENT ARRESTED FOLLOWING THE FIRST ANGIOGRAM. THE PROVIDED ANGIOGRAM IMAGES SHOW A CATHETER IN THE LEFT MAIN AND WHAT APPEARS TO BE A PREVIOUS AIR INJECTION INTO THE CORONARY TREE, OCCLUDING BOTH THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE CIRCUMFLEX ARTERY. A SECOND ANGIO IS INCLUDED THAT SHOWS SOMEWHAT MORE FLOW INTO THE CIRCUMFLEX, BUT PERSISTENT OCCLUSION OF THE LAD. THESE IMAGES ARE CONSISTENT WITH A LARGE AIR INJECTION INTO THE LEFT CORONARIES PRIOR TO OBTAINING THIS ANGIO. IT APPEARS A RESUSCITATION EFFORT WAS MADE BUT WAS UNSUCCESSFUL. ADDITIONAL TRAINING WAS PROVIDED FOR THE CUSTOMER AFTER THE REPORTED INCIDENT. THIS REPORT IS CLOSED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A LEFT HEART CATHETER CORONARY INTERVENTION, THE PATIENT WAS PREPPED; THE PROCEDURE START TIME WAS AT 0938. THE LEAD TECHNICIAN STEPPED AWAY DURING THE INITIAL CVI SET-UP AND THE PHYSICIAN CONNECTED TO THE PATIENT AND THE CVI INJECTOR AND ADVANCED THE CATHETER TO THE PATIENT'S LEFT MAIN ARTERY. AT THE BEGINNING OF THE INJECTION, A PRESSURE LIMIT EXCEEDED ERROR WAS SEEN ON THE CONTROL PANEL OF THE CVI INJECTOR. THE TECH DID A SMALL PURGE OF CONTRAST AND CALLED FOR A SALINE FLUSH. THE PHYSICIAN USED A HAND SYRINGE ON THE SIDE PORT BUT DID NOT FLUSH THE STOPCOCK. A BUBBLE WAS NOTICED ON THE ANGIOGRAM. THE TEAM DISCONNECTED THE PATIENT, DISCARDED THE SYRINGE, AND THE PHYSICIAN ASPIRATED BACK FROM THE PATIENT. THE PATIENT WAS RECONNECTED TO THE CVI INJECTOR, BUT THE STOPCOCK WAS NOT FLUSHED. AN ADDITIONAL AIR BUBBLE WAS SEEN ON THE ANGIOGRAM. THE PATIENT WAS HYPOTENSIVE, AND A CODE BLUE WAS CALLED AT 0947. THE PATIENT EXPIRED AT 1018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626223 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death| H BENADRYL.| FENTANYL.| HEPARIN.| LIDOCAINE.| MIDAZOLAM.