BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 14278734 · Received May 4, 2022

    Report

    Report Number
    2134243-2022-00008
    Event Type
    Death
    Date Received
    May 4, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACIST ANGIOGRAPHIC HAND CONTROLLER KIT, MODEL AT-P54, LOT NUMBER UNKNOWN. THE AT-P54 WAS RETURNED WITH OTHER MANUFACTURER'S EXTENSION TUBING. NO OTHER ACIST CONSUMABLE KITS WERE RETURNED AND THE LOT NUMBERS WERE NOT PROVIDED. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(4) WAS RETURNED ON APRIL 11, 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. TESTING OF THE RETURNED ACIST ANGIOGRAPHIC HAND CONTROLLER KIT, MODEL AT-P54 USED DURING THE EVENT CONFIRMED THAT THERE WERE NO QUALITY ISSUES. 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. AS A FOLLOW-UP ACTION SUBSEQUENT TO THE EVENT, ACIST'S CLINICAL SPECIALIST PROVIDED IN-SERVICE TRAINING TO THE USER FACILITY'S CATH LAB STAFF ON APRIL 26 - 27, 2022. NO CINE-ANGIOGRAMS WERE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE CINE-ANGIOGRAMS ARE RETURNED. THIS REPORT IS CLOSED.

    Description of Event or Problem · 0

    DURING A CORONARY ANGIOGRAPHIC PROCEDURE FOR DYSPNEA AND ABNORMAL STRESS TEST, AFTER THE FIRST INJECTION OF CONTRAST INTO THE PATIENT'S CORONARY ARTERY, AIR WAS INJECTED INTO THE PATIENT, RESULTING IN PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839991 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC: DXT ACIST MEDICAL SYSTEMS ACIST SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death FENTANYL| HEPARIN| NAMIC LOW PRESSURE CONTRAST INJECT. LINE LOT 35267| NITROGLYCERIN| TERUMO PINNACLE INTRODUCER SHEATH 10 CM .038 120490| TERUMO PINNACLE INTRODUCER SHEATH 10 CM .038 143331| VERAPAMIL| VERSED| VISIPAQUE CONTRAST