BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 3403267 · Received September 26, 2013

    Report

    Report Number
    2134243-2013-00012
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST ON (B)(5) 2013 FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. 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 HOSP; THEREFORE, NO ANALYSIS COULD BE MADE OF THESE ITEMS. A COPY OF THE CINE-ANGIOGRAM WAS PROVIDED BY THE HOSP. ACIST'S RISK MGMT 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. IN ADDITION TO LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM, 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 PT 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. BASED ON THE TESTING OF THE INJECTOR, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. BASED ON THE INFO PROVIDED BY THE USER FACILITY, THE CAUSE OF THE EVENT WAS INCOMPLETE CLEARING OF AIR FROM A NON-ACIST DEVICE, A TUOHY-BORST ADAPTER. WHICH WAS LOCATED DISTALLY TO THE ACIST INJECTOR'S ACD SENSOR. A F/U REPORT WILL BE SUBMITTED TO FDA UPON COMPLETION OF REVIEW OF THE CINE-ANGIOGRAM BY ACIST'S MEDICAL ADVISORY BOARD.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: AFTER COMPLETION OF A LEFT HEART CATHETERIZATION AND LEFT VENTRICULOGRAM, AT THE START OF A PERCUTANEOUS CORONARY INTERVENTION (PCI), AIR WAS INJECTED INTO THE PT. THE PHYSICIAN HAD NOT FLUSHED THE TUOHY-BORST ADAPTER COMPLETELY BEFORE CONNECTING IT TO THE CATHETER. THE PT EXPERIENCED HYPOTENSION AND ST SEGMENT ELEVATION. THE PT DID NOT EXPERIENCE CHEST PAIN AND WAS STABLE THROUGHOUT THE PCI. THE PT RECOVERED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487800 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening CORDIS 6FR JR4,| JL4 PIGTAIL 145CM,| BOSTON SCIENTIFIC 2.0 X 15MM EMERGE BALLOON| DILATATION CATHETER,| XB 3.5 GUIDE,| DOPAMINE,| VISIPAQUE (IODIXINOL),| DILATATION CATHETER,| TERUMO 0.14 X 180CM RUNTHROUGH GUIDE,| STENT| MEDTRONIC 2.5 X 2 RESOLUTE INTEGRITY DRUG-ELUTING| BOSTON SCIENTIFIC 2.75 X 15MM QUANTUM APEX| BOSTON SCIENTIFIC CUTTING BALLOON SYSTEM,