BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 883417 · Received July 20, 2007

    Report

    Report Number
    2134243-2007-00005
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    May 18, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST SYRINGE KIT IS THE NON-PATIENT CONTACT KIT THAT IS SET UP AND FILLED WITH THE CONTRAST MEDIA AND IS USED IN ANGIOGRAPHIC PROCEDURE WITH ACIST INJECTOR. SIX SYRINGE KITS WERE RETURNED BY THE CUSTOMER TO ACIST FOR INVESTIGATION. EVALUATION OF RETURNED KITS CONFIRMED THAT THE SYRINGES HAD CRACKED AT THE CONTRACT PORT OF THE SYRINGES. ACIST'S INITIAL ANALYSIS INDICATED THAT UNDER WHAT APPEARS TO BE EXTREME CIRCUMSTANCES USING ACIST SYSTEM, THE CONTRAST PORT OF THE SYRINGE MAY FRACTURE DURING THE INJECTION. FURTHER INFORMATION WAS OBTAINED FROM THE FIELD AND IT WAS DETERMINED THE MAJORITY OF REPORTED FRACTURE HAVE OCCURRED WHILE USING A HIGH FLOW RATE AND SMALL CATHETERS. ACIST MEDICAL ADVISORY BOARD REVIEWED REPORTS OF FAILURES AND THEY FELT THAT THE DEVICE FAILURE WOULD BE OBVIOUS TO THE USER AND DID NOT POSE A PATIENT RISK. EJECTION OF CONTRAST MEDIA IS MESSY AND THERE IS A CHANCE THAT PERSONNEL IN VERY CLOSE PROXIMITY TO THE DEVICE MIGHT BE SPRAYED WITH CONTRAST. TOPICAL CONTRAST EXPOSURE DOES NOT NORMALLY CONSTITUTE A HEALTH RISK. ALTHOUGH PERSONNEL SHOULD ALWAYS WEAR EYE PROTECTION, THERE IS A VERY SMALL CHANCE THAT THEY COULD HAVE CONJUNCTIVAL EXPOSURE. EYE EXPOSURE TO STANDARD CONTRACT MEDIA DOES NOT NORMALLY CARRY SIGNIFICANT RISK OTHER THAN IRRITATION. DUE TO THE ROUTINE EXPOSURE TO BLOOD AND BIOLOGICAL FLUIDS IN THE CATHETERIZATION LABORATORY ENVIRONMENT, EYE WASH STATIONS SHOULD BE AVAILABLE. ALSO, AN INACCURATE OR INCOMPLETE X-RAY IMAGE DUE TO SYRINGE FAILURE MAY BE INCONVENIENT, BUT IS NOT A SUBSTANTIAL PATIENT RISK. THE NUMBER OF ANGIOGRAPHIC RUNS PER PROCEDURE VARIES SUBSTANTIALLY AND IS SOMEWHAT OPERATOR DEPENDENT. RUNS MAY BE ABORTED DUE TO TECHNICAL PROBLEMS (E.G., COVER ON THE X-RAY PEDAL, PANNING PROBLEMS). THE ADDITIONAL X-RAY EXPOSURE FROM AN ABORTED RUN IS SMALL, AS IS THE CONTRAST DOSE. BASED ON THESE CONSIDERATIONS, MAB OPINION WAS THAT THIS TYPE OF DEVICE FAILURE, WHILE NOT DESIRABLE, DOES NOT CONSTITUTE A SIGNIFICANT RISK TO HEALTH. SUBSEQUENTLY, ACIST MEDICAL SYSTEMS EXPANDED ITS INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE PROBLEM. IN COLLABORATION WITH THE CONTRACT MANUFACTURE, ACIST CONDUCTED AN EVALUATION OF THE MANUFACTURING PROCESS AND DETERMINED THAT THE ISSUE WAS ASSOCIATED WITH THE MOLDING PROCESS. A CORRECTIVE ACTION PLAN TO OPTIMIZE THE MANUFACTURING PROCESS HAS BEEN IMPLEMENTED AND ADDITIONAL QUALITY TESTING HAS BEEN DEVELOPED AND IMPLEMENTED TO ELIMINATE THE OCCURRENCE OF THE INCIDENT. ADDITIONAL LOT NUMBERS AND DATES: 0197G; 1/19/2007 AND 0247G; 1/31/2007.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: WHEN USING THE ACIST SYSTEM, THE CONTRAST PORT OF THE SYRINGE BREAKS CAUSING CONTRAST TO BE RELEASED OUTSIDE OF THE BODY. THIS CAUSES INACCURATE IMAGES/INCOMPLETE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST MULTIPLE USE SYRINGE KIT DXT ACIST MEDICAL SYSTEMS, INC. A2000 227K

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR