BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 8693855 · Received June 12, 2019

    Report

    Report Number
    2134243-2019-00014
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 13, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ACIST MULTI-USE SYRINGE, MODEL A2000 LOT 31018M; ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 23218M; ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 33818J. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST EUROPE BV ON 24 JULY 2019. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR SYSTEM. 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. REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR THE FOLLOWING CVI CONSUMABLE KIT LOTS USED DURING THE EVENT: ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 31018M; ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 23218M; AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 33818J. THIS REVIEW CONFIRMED THAT THERE WERE NO MANUFACTURING QUALITY ISSUES FOR THESE LOTS RELATED TO THE REPORTED EVENT. BASED ON THIS INVESTIGATION, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT AND NO INADEQUACIES RELATED TO THE DEVICE LABELING/INSTRUCTIONS FOR USE. ACIST'S MEDICAL ADVISOR REVIEWED A COPY OF THE CINE-ANGIOGRAMS AND INFORMATION RECEIVED FROM THE USER FACILITY. THE ANGIO SHOWS A DIAGNOSTIC STUDY OF A LEFT DOMINANT CIRCULATION AND A FOCAL SEVERE STENOSIS IN A LARGE FIRST OBTUSE MARGINAL (OM) OF THE CIRCUMFLEX (CX). AN INTERVENTION WITH "KISSING STENTS" IS PERFORMED TO THE OM/CX BIFURCATION, WITH A GOOD ANGIOGRAPHIC RESULT. AFTER COMPLETION OF THE PROCEDURE, THE WIRE AND BALLOON ARE REMOVED. ON THE NEXT ANGIOGRAM A SIGNIFICANT BOLUS OF AIR IS INJECTED AND SEEN TO FLOW THROUGH THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CX DISTRIBUTION. THE NEXT IMAGES SHOW OBSTRUCTION OF BOTH THE LAD AND THE DOMINANT CX. THE FINAL IMAGE AGAIN SHOWS NORMAL FLOW THROUGHOUT. AS THE AIR INJECTION OCCURRED AFTER THE REMOVAL OF THE WIRE AND BALLOON, THE AIR MAY HAVE BEEN ENTRAINED IN THE GUIDE AND WAS NOT REMOVED BEFORE THE SUBSEQUENT INJECTION OF CONTRAST MEDIA. BASED ON TESTING AND EVALUATION OF THIS CVI INJECTION SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST MULTI-USE SYRINGE, MODEL A2000, LOT 31018M; ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 23218M; ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 33818J. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, USED DURING THE EVENT, HAS BEEN REQUESTED TO BE RETURNED TO ACIST EUROPE BV FOR EVALUATION. UPON RECEIPT OF THE CVI INJECTION SYSTEM, ANALYSIS WILL BE COMPLETED. THE ACIST CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSPITAL. THE LOT NUMBERS OF THE CONSUMABLE KITS WERE PROVIDED; A REVIEW OF THE MANUFACTURING RECORDS OF THESE LOTS WILL BE COMPLETED.

    Description of Event or Problem · 1

    AT THE END OF AN INTERVENTIONAL CORONARY ANGIOGRAPHY, UPON THE LAST CONTROL INJECTION OF CONTRAST MEDIA, APPROXIMATELY 5-6ML OF AIR WAS INJECTED INTO A PATIENT. THE PATIENT EXPERIENCED ST-SEGMENT DEPRESSION, VENTRICULAR TACHYCARDIA, HYPOTENSION, AND CARDIAC ARREST. THE PATIENT WAS TREATED WITH ADRENALINE, EPHEDRINE, AND CARDIAC MASSAGE. THE PATIENT REMAINED HOSPITALIZED AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486430 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L ABBOTT GUIDEWIRE BMW| ABBOTT SIERRA STENT| ASAHI JL4 GUIDING CATHETER| OKAY II Y CONNECTOR| ULTRAVIST CONTRAST MEDIA