BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 10997296 · Received December 13, 2020

    Report

    Report Number
    2134243-2020-00012
    Event Type
    Death
    Date Received
    December 13, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 16, 2020
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    UDI-DI
    10841716101905
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI SIEMENS, SERIAL NUMBER: (B)(6), WAS RETURNED TO ACIST ON DECEMBER 21, 2020. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CVI CONSUMABLE KIT LOTS USED DURING THE EVENT; ACIST SINGLE-USE MANIFOLD KIT, MODEL: BT2000, LOT: 24020D, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL: AT-P65, 21620T, WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE CINE-ANGIOGRAMS WERE NOT RETURNED FOR EVALUATION THEREFORE COULD NOT BE REVIEWED BY THE ACIST MEDICAL ADVISORY BOARD MEMBER.

    Additional Manufacturer Narrative · 0

    H2: THE CONSUMABLE KITS WERE DISCARDED BY THE USER FACILITY; THE LOTS NUMBERS OF THE CONSUMABLE KITS WERE PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED ON FEBRUARY 05, 2021, FOR THE FOLLOWING CVI CONSUMABLE KIT LOTS USED DURING THE EVENT: ACIST SINGLE-USE MANIFOLD KIT, MODEL: BT2000, LOT: 24020D, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL: AT-P65, 21620T. THIS REVIEW CONFIRMED THAT THERE WERE NO MANUFACTURING QUALITY ISSUES FOR THESE LOTS RELATED TO THE REPORTED EVENT. BASED ON TESTING AND EVALUATION OF THIS CVI INJECTION SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THERE WERE NO CINE-ANGIOGRAMS AVAILABLE FOR THE ACIST MEDICAL ADVISORY BOARD MEMBER TO REVIEW. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI SIEMENS, SERIAL NUMBER (B)(4) WAS REQUESTED TO BE RETURNED FOR EVALUATION ON (B)(6) 2020, AND HAS NOT YET BEEN RECEIVED. THE CONSUMABLE KITS USED DURING THE PROCEDURE WERE DISCARDED BY THE USER FACILITY. THE LOT NUMBERS OF THE CONSUMABLE KITS USED DURING THE EVENT WERE PROVIDED. REVIEW OF THE MANUFACTURING RECORDS WILL BE COMPLETED. COPIES OF THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED TO BE RETURNED TO ACIST FOR THE ACIST MEDICAL ADVISORY BOARD'S EVALUATION. THE ACIST CLINICAL SPECIALIST COMPLETED AN ONSITE FOLLOW-UP VISIT WITH THIS USER FACILITY. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    DURING A LEFT VENTRICLE AND CORONARY CATHETERIZATION (LVC) FOR ELEVATED STRESS, A CORONARY DISSECTION OF THE LEFT MAIN ARTERY OCCURRED AFTER THE SECOND INJECTION OF THE LEFT CORONARY SYSTEM. THE PATIENT'S CONDITION DURING AND AFTER THE EVENT WAS STABLE. THE PATIENT EXPERIENCED CHEST PAIN FOR A PERIOD SUBSEQUENT TO THE EVENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND IT WAS REPORTED BY THE ACIST CLINICAL SPECIALIST THAT THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463540 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SIEMENS 10841716101905

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death FENTANYL.| HEPARIN.| MEDTRONIC 3J GUIDEWIRE LOT GFES2401.| TERUMO GLIDESHEATH.| TERUMO GUIDE CATHETER.| VERAPAMIL.| VERSED.| VISIPAQUE.