BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 2836145 · Received November 9, 2012

    Report

    Report Number
    2134243-2012-00017
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST ON (B)(4) 2012, FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSPITAL; THEREFORE, NO ANALYSIS COULD BE MADE OF THESE ITEMS. ACIST'S MEDICAL ADVISORY BOARD REVIEWED THE INFO AND A COPY OF THE CINE-ANGIOGRAM PROVIDED BY THE HOSPITAL OF THE EVENT: THE DISC INCLUDES 26 ANGIO LOOPS. THE FIRST FIVE LOOPS ARE OF THE LEFT CORONARY CIRCULATION. THE FIRST ANGIO LOOP SHOWS EVIDENCE THAT AIR HAD BEEN INJECTED PRIOR TO THIS ANGIO LOOP BEING RECORDED. BEFORE CONTRAST MEDIA IS INJECTED ON THIS RUN, THE IMAGE SHOWS CONTRAST MEDIA TRAPPED DISTALLY IN THE VESSEL. CORONARY FLOW IS ALREADY SLOW AND THE VESSELS DO NOT COMPLETELY FILL. IT DOES NOT APPEAR THAT AIR WAS INJECTED ON THIS RUN. AS THIS IS THE FIRST RECORDED IMAGE, IT APPEARS THAT AIR WAS INJECTED WHEN THE CATHETER WAS BEING FLUSHED OR FILLED IN ANTICIPATION OF THIS SHOT OR ON A "TEST" SHOT TO SEE IF THE CATHETER WAS APPROPRIATELY SEATED. THE FLOW APPEARS NORMAL BY THE THIRD INJECTION. LOOPS 6-25 SHOW AN INTERVENTION TO AN INITIALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). THERE IS NO EVIDENCE OF AIR INJECTION ON RUNS 3-25. THE CASE WAS AN EMERGENCY CASE WHERE AIR WAS INJECTED WITH THE FIRST INJECTION OF CONTRAST MEDIA; THIS SUGGESTS THAT THE TUBING WAS NOT FLUSHED OF AIR PRIOR TO CONNECTION TO THE CORONARY ANGIOGRAPHIC CATHETER. F/U ON-SITE APPLICATIONS TRAINING WAS COMPLETED BY THE ACIST CLINICAL VASCULAR SPECIALIST WITHIN SEVERAL DAYS FOLLOWING THE EVENT. BASED ON THE RESULTS OF THE TESTING AND ANALYSIS OF THE INJECTOR, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED: PT ADMITTED FOR AN ACTIVE ACUTE MYOCARDIAL INFARCTION. IT WAS SUSPECTED THAT AIR WAS INJECTED ON THE FIRST INJECTION OF CONTRAST INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AS PT WENT INTO VENTRICULAR TACHYCARDIA. PT RECEIVED ADVANCED CARDIAC LIFE SUPPORT BY CHEST COMPRESSION AND RECOVERED. THE CASE WAS RESUMED WITH A MANUAL MANIFOLD SET UP. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED OF THE RIGHT POSTERIOR DESCENDING ARTERY. PT WAS SENT TO ICU AFTER COMPLETION OF THE PCI. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CVI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R NC BALLOON| BOSTON SCIENTIFIC TGR 4FR CATHETER| BOSTON SCIENTIFIC SPRINTER BALLOON 2.0X12 & 2.5X12| BOSTON SCIENTIFIC PIGTAIL CATHETER 4FR| BOSTON SCIENTIFIC 2.75X12 VISION STENT AND| BOSTON SCIENTIFIC JL4 4FR| BOSTON SCIENTIFIC BMW WIRE