BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 10390520 · Received August 11, 2020

    Report

    Report Number
    2134243-2020-00008
    Event Type
    Death
    Date Received
    August 11, 2020
    Date of Event
    July 13, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H2: DESPITE REQUESTS BY ACIST FOR THE RETURN OF THE CVI INJECTOR SERIAL NUMBER: (B)(6) FOR INVESTIGATION, THE USER FACILITY ELECTED NOT TO RETURN THE SYSTEM. SHOULD THE SYSTEM BE RETURNED AT A FUTURE DATE, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA. H6: ADVERSE EVENT PROBLEM CODES 213 AND 67 ARE BASED ON REVIEW OF HISTORICAL DATA REPORTED UNDER 2134243-2020-00008 FOLLOW UP 1. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4) HAS NOT YET BEEN RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED ON SEPTEMBER 4, 2020, FOR THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, INJECTOR SERIAL NUMBER (B)(4). THIS REVIEW CONFIRMED THAT THERE WERE NO QUALITY ISSUES OR DEVIATIONS DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED AND THE LOT NUMBERS ARE NOT KNOWN. THE ACIST MEDICAL ADVISORY BOARD MEMBER VIEWED THE CINE-ANGIOGRAMS AND PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: DURING A CORONARY CATHETERIZATION PROCEDURE, AN AIR INJECTION OCCURRED PRIOR TO OR AT THE TIME OF THE FIRST ANGIOGRAPHIC INJECTION INTO THE LEFT MAIN CORONARY ARTERY. THE TWO IMAGES AVAILABLE SHOW AN INJECTION DEMONSTRATING OCCLUSION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND CIRCUMFLEX ARTERY. THESE IMAGES ARE CONSISTENT WITH AIR INJECTION HAVING OCCURRED JUST BEFORE THE RECORDED IMAGE. SINCE IT WAS APPARENT ON THIS FIRST INJECTION, THIS IS MOST LIKELY DUE TO AIR IN THE CATHETER OR PATIENT TUBING THAT WAS NOT FULLY CLEARED BY THE USER PRIOR TO THE INJECTION. THERE WERE NO OTHER IMAGES IN THE FILE. PRESUMABLY, THE PATIENT ARRESTED, AND NO MORE IMAGES WERE OBTAINED DURING THE ATTEMPT AT RESUSCITATION. UPON COMPLETION OF INVESTIGATION OF THE SYSTEM, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), CONSUMABLES USED DURING THE EVENT, AND COPIES OF THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED TO BE RETURNED TO ACIST FOR INVESTIGATION. UPON COMPLETION OF INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AFTER THE INITIAL REPORT. A RIGHT AND LEFT CATHETERIZATION WAS PERFORMED FOR CONSTRICTIVE PERICARDITIS (CP) AND SHORTNESS OF BREATH (SOB). IMMEDIATELY DURING THE FIRST INJECTION OF CONTRAST, A DAMPENED WAVEFORM OCCURRED AND IMMEDIATELY THE PATIENT WENT INTO CARDIAC ARREST AND A CODE WAS CALLED. THERE WAS AN AIR INJECTION OF AN UNKNOWN AMOUNT AND AIR WAS NOTED ON THE CINE-ANGIOGRAM IMAGE 1042. RESUSCITATION EFFORTS WERE PERFORMED FOR 45 MINUTES WITHOUT SUCCESS. THE PATIENT EXPIRED. DURING THE EVENT THE PATIENT EXPERIENCED ST SEGMENT ELEVATION, ABNORMAL HEART RHYTHM AND BLOOD PRESSURE <90 MMHG SYSTOLIC.

    Description of Event or Problem · 1

    DURING A CATHETERIZATION PROCEDURE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), THE USER OBSERVED AN AIR BUBBLE; THE USER REPORTED THAT THEY DID NOT SEE A WARNING DISPLAYED BY THE INJECTOR SYSTEM. THE AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854717 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death NOVAPLUS VISIPAQUE.