BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 10311815 · Received July 22, 2020

    Report

    Report Number
    2134243-2020-00006
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H2: REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED ON AUGUST 19, 2020, FOR THE FOLLOWING CVI CONSUMABLE KIT LOTS USED DURING THE EVENT, ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 6220K; ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 00920W, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P65, LOT 06720M. THIS REVIEW CONFIRMED THAT THERE WERE NO QUALITY ISSUES OR DEVIATIONS DURING THE MANUFACTURING OF THESE LOTS RELATED TO THE REPORTED EVENT. ACIST MEDICAL ADVISORY BOARD MEMBER VIEWED THE CINE-ANGIOGRAMS AND PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE ANGIO FILES INCLUDE ANGIOGRAPHIC IMAGES OF LEFT- SIDED CORONARY ANGIO. THESE ARE UNREMARKABLE AND DO NOT SHOW AIR INJECTION. THERE ARE TWO ANGIO INJECTIONS OF THE SAPHENOUS VEIN GRAFTS (SVG) TO THE RIGHT CORONARY ARTERY (RCA). THE FIRST LABELED IMAGE SHOWS SOME STREAMING OF THE FLOW ALONG THE MID DISTAL PORTION OF THE GRAFT AND THIS DOES LOOK LIKE A SMALL AMOUNT OF AIR. IF IT IS AIR, IT PASSES WITHOUT APPARENT OBSTRUCTION TO THE RIGHT CORONARY ARTERY (RCA) AND THE FLOW TO THE RIGHT CORONARY ARTERY (RCA) IN THE NEXT IMAGE APPEARS NORMAL. IT IS DIFFICULT TO QUANTIFY THE AMOUNT OF AIR, AS IT DOES ALSO APPEAR TO BE A MIXTURE OF CONTRASTED AND NONCONTRASTED BLOOD IN THIS SAME AREA. ON THE NEXT INJECTION IMAGE THERE IS CLEAR STREAMING OF NONCONTRASTED BLOOD IN THIS SAME AREA, SUGGESTING THAT THIS MAY BE THE CAUSE OF THE APPEARANCE OF AIR ON THE PREVIOUS IMAGE. THE APPEARANCE ON THE PREVIOUS RUN IS CONSISTENT WITH AIR INJECTION, BUT THE STREAMING EFFECT IS JUST AS LIKELY THE EXPLANATION. IT IS DIFFICULT TO SEE EXACTLY WHERE THE NATIVE RIGHT CORONARY ARTERY (RCA) INTERSECTS WITH THE GRAFT - BUT SOME OF THIS APPEARANCE DESCRIBED MAY BE DUE TO NONCONTRASTED BLOOD FROM THE NATIVE VESSEL MERGING WITH THE COLUMN OF CONTRASTED BLOOD COMING FLOWING DOWN THE GRAFT. REGARDLESS, IT DOES NOT APPEAR THAT THE PATIENT SUFFERED ANY INJURY FROM THIS EVENT. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 06220K; ACIST SINGLE-USE MANIFOLD KIT, MODE BT2000, LOT 00920W; ACIST ANIGOTOUCH HAND CONTROLLER KIT, LOT 06720M. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST ON JUNE 30, 2020. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED. A DEVICE HISTORY OF THESE LOTS WILL BE REVIEWED. ACIST RECEIVED A COPY OF THE CINE-ANGIOGRAMS OF THE EVENT. THESE WILL BE REVIEWED BY ACIST'S MEDICAL ADVISOR. UPON COMPLETION OF THESE REVIEWS, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA. THE ACIST CLINICAL SPECIALIST COMPLETED AN ONSITE FOLLOW-UP VISIT WITH THIS USER FACILITY ONE DAY AFTER THE 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. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT AND NO INADEQUACIES RELATED TO THE DEVICE LABELING/INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED, WHILE PERFORMING A LEFT HEART CATHETERIZATION (LHC) FOR A SAPHENOUS VEIN GRAFT, THE PHYSICIAN NOTED THAT AN UNKNOWN AMOUNT OF AIR HAD BEEN VISUALIZED ON THE X-RAY. THE PATIENT WAS DETERMINED TO BE STABLE HOWEVER, THEY EXPERIENCED SEVERAL MINUTES OF CHEST PAIN. THE CHEST PAIN WAS RESOLVED AFTER THE ADMINISTRATION OF FENTANYL. THERE WAS NO INJURY REPORTED. THE PATIENT RECOVERED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772561 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O BOSTON-SCIENTIFIC 5FR AL-1 CATHETER| HEPARIN| VERSED