BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 949578 · Received April 20, 2007

    Report

    Report Number
    2134243-2007-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2007
    Date of Event
    March 22, 2007
    Report Date
    April 20, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: THE ACIST INJECTION SYSTEM (501K #K991103 AND K010390) INVOLVED WAS TAKEN OUT OF SERVICE AND IS BEING RETURNED TO ACIST FOR TESTING. PRELIMINARY INVESTIGATION HAS DETERMINED THAT UNDER SOME SPECIFIC IMAGING SEQUENCE PARAMETERS AND INJECTION CIRCUMSTANCES WHEN USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM TO SYNCHRONIZE WITH A FLUOROSCOPIC X-RAY SYSTEM IT IS POSSIBLE TO INJECT CONTRAST INTO THE PATIENT BUT NOT HAVE THE DIAGNOSTIC IMAGE SEQUENCE COMPLETED AND POSSIBLY REQUIRING A SECOND DOSE OF CONTRAST MEDIA. REVIEW OF THE ACIST COMPLAINT DATABASE FROM 2004 TO 2007 IDENTIFIED ONLY ONE REPORTED COMPLAINT ASSOCIATED WITH THIS PROBLEM. ON APRIL 5, 2007, THE MEDICAL ADVISORY BOARD OF ACIST MEDICAL SYSTEMS MET TO DISCUSS THE POTENTIAL CLINICAL CONSEQUENCE IF A PATIENT REQUIRED A SECOND DOSE OF CONTRAST MEDIA IN ORDER TO OBTAIN THE NEEDED IMAGE. THE ACIST MAB DETERMINED IN THE VAST MAJORITY OF PATIENTS, THIS WOULD NOT HAVE A CLINICAL CONSEQUENCE, HOWEVER, IN PATIENTS PREDISPOSED TO CONTRAST-INDUCED NEPHROPATHY IT IS POSSIBLE THAT THE ADDITIONAL DOSE COULD CAUSE TRANSIENT RENAL FAILURE AND IN THE WORST OF ALL CASES, TEMPORARY DIALYSIS. ABOUT 1 IN 20 PTS UNDERGOING ANGIOGRAPHY ARE AT ELEVATED RISK OF CONTRAST NEPHROPATHY (E.G., SERUM CREATININE >1.7 MG/DL IN NON-DIABETICS AND >1.5 MG/DL IN DIABETICS). OF THOSE, THE MAB ESTIMATED THAT THE RISK OF CLINICALLY SIGNIFICANT CONTRAST INDUCED NEPHROPATHY FROM AN EXTRA DOSE OF CONTRAST WOULD BE NO MORE THAN 1 IN 10. AS A RESULT, THE MAB ESTIMATED THAT THE RISK OF CONTRAST-INDUCED NEPHROPATHY WOULD BE ABOUT 1 IN 200,000 AS A RESULT OF THIS ISSUE. AVOIDING THE INVOLVED IMAGING SEQUENCE PARAMETERS WOULD COMPLETLEY ELIMINATE ANY RISK.

    Description of Event or Problem · 1

    USER FACILITY REPORTS: A PROBLEM WITH THE SYNCHRONIZATION BETWEEN THE ACIST CVI CONTRAST INJECTION SYSTEM AND FLUOROSCOPIC X-RAY SYSTEM. DURING LARGE INJECTIONS, THE SYNCHRON INJECTION DID NOT FUNCTION.

    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 NO INFO