BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 2233947 · Received August 30, 2011

    Report

    Report Number
    2134243-2011-00009
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K99110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A SERVICE TECHNICIAN OF ACIST'S (B)(4) DISTRIBUTOR VISITED HOSPITAL AND TESTED THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THIS TESTING. THE CONSUMABLE KITS USED DURING THE EVENT WERE TESTED UNDER SIMULATED USE AND PASSED FUNCTIONAL TESTING. THERE ARE NO ANGIOGRAPHIC IMAGES AVAILABLE TO VISUALLY CONFIRM IF AIR INJECTION OCCURRED BECAUSE ONLY SALINE WAS INJECTED DURING THE USE OF THE ROTABLATOR. DURING THE PROCEDURE, THE INJECTOR SYSTEM DISPLAYED AN "AIR COLUMN DETECTED" MESSAGE AND STOPPED THE INJECTION. 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 RESULTS OF THE TESTING OF THE INJECTION SYSTEM AND CONSUMABLE KITS USED DURING THE EVENT, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. THE CAUSE OF THIS EVENT IS INCONCLUSIVE. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED: DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF A PT'S CIRCUMFLEX BRANCH OF THE LEFT CORONARY ARTERY, SEGMENT 12, USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, TO INJECT SALINE DURING USE OF A ROTABLATOR, THE PT EXPERIENCED CARDIAC ARREST. DURING OPERATION OF THE ROTABLATOR, THE ACIST INJECTION SYSTEM DISPLAYED AN "AIR COLUMN DETECTED" ALERT MESSAGE AND THE SALINE INJECTION WAS STOPPED BY THE ACIST INJECTION SYSTEM. THE PHYSICIAN CONFIRMED PRESENCE OF AIR IN THE HIGH-PRESSURE TUBING, THREE-WAY STOPCOCK, AND Y-CONNECTOR EXTENSION TUBING, DISTAL TO THE AIR COLUMN DETECT SENSOR. WHEN THE PHYSICIAN ASPIRATED THE CATHETER USING A HAND SYRINGE, THE PHYSICIAN FOUND APPROX 2-3CC OF AIR IN THE ASPIRATED BLOOD AND THAT THE 350CC SALINE BAG HAD EMPTIED. WHILE PERFORMING REMOVAL OF THE AIR FROM THE CATHETER, THE PHYSICIAN NOTED THAT THE PT'S CONDITION HAD CHANGED, AND THE PT WAS EXPERIENCING CARDIAC ARREST. THE PT WAS INTUBATED AND RESUSCITATED WITH HEART MESSAGE, INTRA-AORTIC BALLOON PUMP (IABP), AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). THE PHYSICIAN RESTARTED THE PTCA WITH A BALLOON CATHETER AND WITHOUT THE ROTABLATOR. THE PTCA WAS COMPLETED. A CT SCAN OF THE PT'S CHEST AND HEAD WAS PERFORMED AND THERE WAS NO EVIDENCE OF AIR EMBOLISM. THE PT WAS MOVED TO THE HOSPITAL'S CRITICAL CARE UNIT. THE PT SUBSEQUENTLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. (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 60 YR Hospitalization| L BOSTON SCIENTIFIC ROTABLATOR 1.5MM