BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 8889529 · Received August 13, 2019

    Report

    Report Number
    2134243-2019-00017
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST ON AUGUST 7, 2019. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE ACIST CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN; THEREFORE, ACIST IS UNABLE TO INVESTIGATES THESE ITEMS. 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. ACIST'S MEDICAL ADVISORY BOARD REVIEWED A COPY OF THE CINE-ANGIOGRAMS AND INFORMATION RECEIVED FROM THE USER FACILITY FROM THE EVENT: THE FIRST IMAGE IS OF A RIGHT CORONARY ARTERY (RCA) CATHETER THAT IS NOT ENGAGED YET INTO THE RCA. THE SECOND IMAGE IS ANOTHER ANGIO OF THE RCA CATHETER IN THE AORTA, STILL NOT YET ENGAGED IN THE RCA. HOWEVER, THERE IS A SMALL BUBBLE OF AIR VISIBLE IN THE DISTAL END OF THE CATHETER THAT IS INJECTED. THE THIRD IMAGE IS AN INJECTION OF CONTRAST MEDIA INTO THE RCA, SHOWING OCCLUSION IN PROXIMAL MID VESSEL; THIS OCCLUSION IS CONSISTENT WITH AIR HAVING BEEN INJECTED SHORTLY BEFORE THIS IMAGE. AIR WAS NOT VISIBLE ON THIS IMAGE. THE FOURTH AND FIFTH IMAGES ARE OF THE RCA WITH NORMAL FLOW. THE SIXTH IMAGE IS A LEFT VENTRICULOGRAM. THE VENTRICULOGRAM IS NORMAL AND NO AIR INJECTION IS SEEN. THE SEVENTH - NINTH IMAGES ARE OF THE LEFT CORONARIES AND ARE NORMAL. IT APPEARS THAT THE AIR INJECTION WAS INTO THE RCA AT THE BEGINNING OF THE PROCEDURE, WHEN THE CATHETER WAS ATTEMPTED TO BE ENGAGED INTO THE RCA, UPON THE FIRST INJECTIONS OF CONTRAST MEDIA. THE MOST LIKELY CAUSE OF AIR ENTRY DURING FIRST INJECTIONS OF CONTRAST MEDIA IS FAILURE TO CLEAR AIR FROM THE TUBING AND CATHETER AT SETUP. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR SYSTEM. DEVICE LABELING/INSTRUCTIONS FOR USE. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DURING AN OUTPATIENT DIAGNOSTIC CARDIAC CATHETERIZATION, AIR WAS INJECTED INTO THE PATIENT'S CORONARY ARTERY DURING LEFT VENTRICULOGRAPHY (LV GRAM). THE PATIENT EXPERIENCED CHEST PAIN, ABNORMAL HEART RHYTHM (VENTRICULAR TACHYCARDIA), BLOOD FLOW RESTRICTION WHICH RESULTED IN SLOW FLOW, ST-SEGMENT ELEVATION, HYPOTENSION AND EVIDENCE OF MYOCARDIAL INFARCTION. THE PATIENT WAS INTUBATED AND REQUIRED AN INTRA-AORTIC BALLOON PUMP (IABP), SWAN-GANZ CATHETERIZATION, A TEMPORARY PACEMAKER, MEDICATION SUPPORT, AND DEFIBRILLATION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO BE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682258 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R MEDTRONIC 5 FR. JR4 DIAGNOSTIC CATHETER, DXT5JR40| OMNIPAQUE (LOHEXOL) CONTRAST MEDIA