BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 5710765 · Received June 9, 2016

    Report

    Report Number
    2134243-2016-00010
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 25, 2016
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST ON APRIL 5, 2016 FOR TESTING. BASED ON ANALYSIS OF THE INJECTOR SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT. THE CONSUMABLE KITS USED DURING THE EVENT WERE ANALYZED AND TESTING CONFIRMED THE CONSUMABLE KITS PERFORMED TO ACIST MANUFACTURING SPECIFICATIONS. A COPY OF THE CINE-ANGIOGRAM WAS PROVIDED BY THE USER FACILITY ON MAY 23, 2016. THE ACIST MEDICAL ADVISORY BOARD (MAB) EVALUATED THE CINE-ANGIOGRAMS. A SMALL AIR BUBBLE WAS OBSERVED ON THE CINE-ANGIOGRAM AFTER A STENT WAS PLACED IN THE LIMA-LAD ANASTOMOSIS; HOWEVER, THE MAB INDICATED THE BUBBLE WAS TOO SMALL TO CAUSE PROBLEMS. IT IS UNKNOWN IF THE PATIENT SYMPTOMS WERE DUE TO THE AIR INJECTION OR PLACEMENT OF THE STENT INTO A THROMBOTIC LESION. THE ORIGIN OF THE AIR BUBBLE IS UNCERTAIN (ACIST TUBING OR NON-ACIST DISTAL Y-CONNECTOR). THE ACIST CONTRAST INJECTION SYSTEM IS EQUIPPED WITH AN AIR COLUMN DETECT SENSOR. THE AIR COLUMN DETECT SENSOR SENSES AIR IN THE PROXIMAL END OF THE HIGH-PRESSURE (INJECTION) TUBING. IF AIR IS DETECTED IN THE TUBING, ALL FLUID DELIVERY FUNCTIONS ARE DISABLED. PER THE ACIST CVI USERS MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PATIENT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. 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. BASED ON SERVICE TESTING PERFORMED ON THIS SYSTEM AND CONSUMABLE ANALYSIS, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) USING THE ACIST CONTRAST INJECTION SYSTEM, MODEL CVI, AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED ST SEGMENT DEPRESSION AND ABNORMAL HEART RHYTHMS (BRADYARRYTHMIAS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366894 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening