BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 3010924 · Received March 14, 2013

    Report

    Report Number
    2134243-2013-00002
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 14, 2013
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THE ACIST CONTRAST INJECTION SYSTEM, MODEL CVI, WAS TESTED BY ACIST'S (B)(4) SERVICE CENTER. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THIS TESTING. ON (B)(4) 2013, THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED BY ACIST EUROPE'S SERVICE CENTER. THE INJECTOR SYSTEM MET THE PRE-ESTABLISHED SPECIFICATIONS. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSPITAL; THEREFORE, NO ANALYSIS COULD BE MADE OF THESE ITEMS. 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 TESTING OF THE INJECTOR, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF REVIEW OF THE CINE-ANGIOGRAM BY ACIST'S MEDICAL ADVISORY BOARD.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED, DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY, FOR TREATMENT OF ACUTE INFERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI), AIR WAS INJECTED INTO THE PATIENT AFTER POST-DILATION OF THE STENT. THE PATIENT EXPERIENCED CHEST PAIN AND ST-SEGMENT ELEVATION FOR A DURATION OF 20 MINUTES. THE PATIENT RECOVERED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108163 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS INC. CVI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening CLOPIDOGREL (CLOPIDOGREL)| ASPIRIN (ACETYLSALICYLIC ACID)| BIVALIRUDIN (BIVALIRUDIN)