BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 10311675 · Received July 22, 2020

    Report

    Report Number
    2134243-2020-00005
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 22, 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. THERE WERE NO CINE-ANGIOGRAMS AVAILABLE FOR THE ACIST MEDICAL ADVISORY BOARD MEMBER TO REVIEW. 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 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

    DURING A LEFT HEART CATHETERIZATION (LHC) AND PERCUTANEOUS CORONARY INTERVENTION (PCI), A TEST INJECTION OF CONTRAST MEDIA WAS DONE BEFORE THE FINAL IMAGE WAS TAKEN, WITH THE GUIDE CATHETER STILL IN PLACE FROM THE PREVIOUS INJECTION. A POSSIBLE AIR INJECTION WAS OBSERVED ON THE IMAGES. THE PATIENT EXPERIENCED CHEST PAIN, A HEADACHE WHICH SPONTANEOUSLY RESOLVED, AND ST-SEGMENT ELEVATION OF A DURATION OF APPROXIMATELY ONE MINUTE. THE PATIENT RECOVERED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772528 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening FENTANYL| HEPARIN| MEDTRONIC EBU 3.0 GUIDE CATHETER| MEDTRONIC RESOLUTE ONYX STENT 3.5 X 18| MERIT INDEFLATOR KIT| OMNIPAQUE| VERSED