BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 19417886 · Received May 29, 2024

    Report

    Report Number
    2134243-2024-00008
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED FOR EVALUATION, BUT HAVE NOT YET BEEN RETURNED TO ACIST. A CLINICAL ASSESSMENT BY AN ACIST MEDICAL ADVISORY BOARD MEMBER WILL BE PERFORMED ON THE CINE-ANGIOGRAMS UPON RECEIPT. A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE CLINICAL ASSESSMENT OF THE CINE-ANGIOGRAMS ASSESSMENT AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON (B)(6) 2024. 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. THIS REPORT IS CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO ACIST THAT DURING AN ELECTROPHYSIOLOGY (EP) CRYOABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AF) WHILE ADVANCING INTO LEFT ATRIUM, THE NORMAL SALINE BAG CONNECTED TO THE ACIST CVI MANIFOLD KIT, BECAME EMPTY. AIR ENTERED THROUGH THE ACIST CONSUMABLE TUBING AND INTO THE PATIENT. THERE WAS NO AIR COLUMN DETECTED MESSAGE FROM THE CVI INJECTOR AND THE AIR WAS DETECTED IMMEDIATELY BY THE SCRUB NURSE ON THE IMAGES. THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) ARREST SHOCK X1, HYPOTENSION, ABNORMAL HEART RHYTHM, EVIDENCE OF MYOCARDIAL INFARCTION, AND CARDIAC BIOMARKER ELEVATION. THE DEFIBRILLATOR WAS USED ON THE PATIENT AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY (TUH) AND PLACED INTO A HYPERBARIC CHAMBER. THE REPORT STATES NO OTHER STOPCOCK OR OTHER MANUFACTURER'S TUBING WAS ATTACHED TO THE CVI CONSUMABLES. THE PATIENT SUBSEQUENTLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940523 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| L OMNIPAQUE 300.