BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 10390472 · Received August 11, 2020

    Report

    Report Number
    2134243-2020-00007
    Event Type
    Death
    Date Received
    August 11, 2020
    Date of Event
    July 10, 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 2134243-2020-00007 FOLLOW UP 1. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6) 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)(6) . 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, THE FIRST INJECTION SHOWS DYE TRAPPED IN THE PROXIMAL CIRCUMFLEX ARTERY AND LEFT ANTERIOR DESCENDING ARTERY WITH ASSOCIATED OCCLUSION. THERE IS ONE BUBBLE THAT IS SEEN TO BE INJECTED - CONSISTENT WITH THE ASSUMPTION THAT AIR HAD ALSO BEEN INJECTED PRIOR TO THIS RECORDED INJECTION, AND THAT THIS WAS THE CAUSE OF THE OCCLUSION AND SUBSEQUENT CARDIAC ARREST. ADDITIONAL IMAGES SHOW THAT WIRES WERE PASSED IN THE LEFT ANTERIOR DESCENDING ARTERY AND CIRCUMFLEX ARTERY IN AN ATTEMPT TO CLEAR THE OBSTRUCTION. THESE IMAGES SHOW DYE TRAPPED THROUGHOUT A LONGER REGION OF THE CIRCUMFLEX ALSO CONSISTENT WITH THE INITIAL AIR INJECTION. THE OCCLUSION WAS APPARENT ON THIS FIRST INJECTION AND IS MOST LIKELY DUE TO AIR IN THE CATHETER OR PATIENT TUBING THAT WAS NOT FULLY CLEARED BY THE USER PRIOR TO THE INJECTION. 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

    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
    858784 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death NOVAPLUS VISIPAQUE.