BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST MULTI-USE SYRINGE

    MDR report key: 897277 · Received August 7, 2007

    Report

    Report Number
    897277
    Event Type
    Malfunction
    Date Received
    August 7, 2007
    Date of Event
    July 26, 2007
    Report Date
    August 7, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ANGIOGRAPHY AND STENT PLACEMENT FOR STENOSIS, THE ACIST SYRINGE LEAKED DURING THE LV PORTION OF THE ANGIOGRAM. A 4 FRENCH CATHETER WAS IN USE DURING THE PROCEDURE. CATH LAB REPORTS THIS IS THE THIRD LEAKING INCIDENT THIS WEEK. THE ACIST SYRINGE LEAKED DURING THE REST OF THE CASE. SYRINGE WAS SAVED. A COMPLAINT WAS FILED WITH ACIST MEDICAL SYSTEMS. ACIST REPLIED THAT THEIR INITIAL ANALYSIS INDICATES THAT UNDER EXTREME CIRCUMSTANCES USING THE ACIST SYSTEM, THE CONTRAST PORT OF THE SYRINGE MAY FRACTURE DURING INJECTION AND CAUSE CONTRAST TO BE RELEASED INTO THE LAB ENVIRONMENT. ALL REPORTED FRACTURES HAVE OCCURRED WHILE USING SMALL CATHETERS (3FR - 5FR) WITH FLOW RATES OF GREATER THAN 10 ML/SEC, INJECTION VOLUMES OF >20 ML, AND RISE TIMES <.2 SECONDS. ACIST IS CURRENTLY INVESTIGATING THESE REPORTS. ACIST SUGGESTED USING A FLOW RATE OF SLOWER THAN 10 ML/SEC AND RISE TIMES OF LONGER THAN 0.6 SECONDS. PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED AND PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST MULTI-USE SYRINGE SYRINGE, CONTRAST INJECTION DXT ACIST MEDICAL SYSTEMS, INC. A2000 0247G

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR