BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 14146759 · Received April 19, 2022

    Report

    Report Number
    2134243-2022-00005
    Event Type
    Death
    Date Received
    April 19, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACIST AT-P54 LOT# 00522K, ACIST BT2000 LOT #28721F, ACIST A2000, LOT # 19521D. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(4) WAS RETURNED ON MARCH 24, 2022. 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 THE 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 CONSUMABLES ACIST AT-P54 LOT# 00522K, ACIST BT2000 LOT #28721F, ACIST A2000, LOT # 19521D, WERE RETURNED FOR EVALUATION. TESTING OF THE CONSUMABLES USED DURING THE EVENT CONFIRMED THAT THERE WERE NO QUALITY ISSUES FOUND. THE CLINICAL ASSESSMENT BY THE ACIST MEDICAL ADVISORY BOARD MEMBER WAS CONDUCTED ON MARCH 26, 2022, AND IS AS FOLLOWS: THE ADVERSE EVENT FORM DESCRIBES AN AIR INJECTION THAT OCCURRED ON THE FIRST ANGIOGRAPHIC INJECTION. THE ANGIOGRAM WAS BEING PERFORMED AS PART OF AN EVALUATION PRIOR TO A PLANNED TAVI PROCEDURE. THE ANGIOGRAPHIC IMAGE SHOWS A LEFT CORONARY CATHETER IN THE ASCENDING AORTA (AO) AND CONTRAST DYE TRAPPED IN THE LEFT CORONARIES. PRESUMABLY, THIS IMAGE WAS TAKEN SHORTLY AFTER THE AIR WAS INJECTED. GIVEN THE FACT THAT TAVI WAS PLANNED, WE CAN ASSUME THE PATIENT HAD SEVERE AORTIC STENOSIS. THIS MAKES IT MUCH HARDER FOR THE PATIENT TO RECOVER FROM THE AIR INJECTION. THE REPORT FORM MAKES MENTION OF AN ATTEMPT AT RESUSCITATION THAT INCLUDED A BALLOON VALVULOPLASTY. THE FACT THAT THE AIR INJECTION OCCURRED ON THE FIRST INJECTION, IT IS MOST LIKELY THAT THERE WAS AIR THAT WAS NOT COMPLETELY EVACUATED FROM THE CATHETER, THE TUBING OR THE CONNECTORS, PRIOR TO INJECTION. THIS REPORT IS CLOSED.

    Description of Event or Problem · 0

    USER FACILITY REPORTED THAT AT THE BEGINNING OF AN ANGIOGRAPHIC PROCEDURE ON AN (B)(6) WOMAN, AN AIR INJECTION OF APPROXIMATELY 5 CC'S OCCURRED IN THE LEFT MAIN CORONARY SYSTEM. THE PATIENT EXPERIENCED CARDIOGENIC SHOCK, ELECTROMECHANICAL DISASSOCIATION, CHEST PAIN, ST-SEGMENT CHANGES, ELEVATION, ABNORMAL HEART RHYTHM (LEFT BUNDLE BRANCH BLOCK LLB), BLOOD PRESSURE <90 MMHG SYSTOLIC AND EVIDENCE OF MYOCARDIAL INFARCTION. THE PATIENT EXPIRED AFTER ONE HOUR OF RESUSCITATION (AORTIC VALVE VALVULOPLASTY, ADRENALINE, ISUPREL AND OXYGEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717629 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC: DXT ACIST MEDICAL SYSTEMS ACIST SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Hospitalization| D| L HEPARIN (UFH) 2500 UI| VERAPAMIL 25 MG| VISIPAQUE 320 - 200ML| VISIPAQUE 320, 200 ML