BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 20848139 · Received December 4, 2024

    Report

    Report Number
    2134243-2024-00013
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    UDI-DI
    40841716101425
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: PATIENT AGE IS ESTIMATED. NO PATIENT INFORMATION WAS PROVIDED. 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 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 INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON JANUARY 10, 2025. 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

    DURING A PLANNED ELECTROPHYSIOLOGICAL EXAMINATION WITH ABLATION OF THE PULMONARY VEINS, WHEN USING SALINE TO FLUSH THE ACIST CONSUMABLE KITS ATTACHED TO THE ACIST INJECTION SYSTEM, MODEL CVI, THERE WERE REPEATED MASSIVE AIR BUBBLES IN THE CONSUMABLE TUBING. THE USER RESOLVED THE ERROR BY CHANGING THE DELTAMEDICA SALINE INFUSION CONTAINER CONNECTED TO THE CVI CONSUMABLE KIT WITH ANOTHER MANUFACTURER'S SALINE CONTAINER (BRAUN). THE PROCESS OF CHANGING THE SALINE BAG RESULTED IN AN AIR BEING INJECTED INTO THE PATIENT'S CORONARY ARTERIES. THE PATIENT REQUIRED RESUSCITATION. THE USER NOTICED THAT THE WALLS OF THE DELTAMEDICA GMBH, SALINE CONTAINER ARE HARDER THAN THOSE OF THE BRAUN SALINE CONTAINER. EMPTYING THE BOTTLE COULD RESULT IN THE FORMATION OF NEGATIVE INTERNAL PRESSURE WITH A SUBSEQUENT SUCTION EFFECT. ADDITIONALLY, THE RUBBER PLUG IS HARDER THAN THAT THE BRAUN CONTAINER AND IT REQUIRES SIGNIFICANTLY MORE FORCE TO BE PIERCED WITH THE INFUSION CANNULA. THE HARDNESS OF THE RUBBER CAN LEAD TO INADEQUATE SEALING. THE DELTAMEDICA ISOTONIC SODIUM CHLORIDE SOLUTION, 0.9% PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY ACIST. IT IS MANUFACTURED BY DELTAMEDIA GMBH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941855 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI 40841716101425

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Hospitalization| L DELTAMEDICA ISOTONIC SODIUM CHLORIDE SOLUTION 0.9%