BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 1321670 · Received December 17, 2008

    Report

    Report Number
    2134243-2008-00013
    Event Type
    Malfunction
    Date Received
    December 17, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 16, 2008
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THE PROBLEM TO INTERNATIONAL AFFILIATE. THE DISTRIBUTOR DISPATCHED THEIR SERVICE TECHNICIAN TO VISIT THE HOSPITAL TO INVESTIGATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN CONFIRMED THAT ACIST ANGIOGRAPHIC INJECTION SYSTEM MODEL CVI WAS INTERFACED WITH A SIEMENS X-RAY SYSTEM. THE HOSPITAL'S RADIOLOGY TECHNICIAN REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION PROCEDURE, THE SIEMENS X-RAY SYSTEM DID NOT COMPLETE THE IMAGING SEQUENCE AFTER THE CONTRAST INJECTION WAS INITIATED BY THE ACIST INJECTOR. BASED ON OUR EVALUATION OF THE REPORTED INCIDENT, WE HAVE DETERMINED THAT UNDER SPECIFIC IMAGING SEQUENCE PARAMETERS WHEN USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM INTERFACED WITH A FLUOROSCOPIC X-RAY SYSTEM, IT IS POSSIBLE TO INJECT CONTRAST MEDIA INTO THE PATIENT WITHOUT THE DIAGNOSTIC IMAGE SEQUENCE BEING COMPLETED. THE PHYSICIAN WOULD BE AWARE OF THIS LACK OF X-RAY IMAGE AND WOULD HAVE THE OPTION OF CONTINUING WITH THE INJECTION AND IMAGING OR COULD DISCONTINUE, IF WARRANTED PER THE PATIENT'S HEALTH HISTORY. PER ACIST'S MEDICAL ADVISORY BOARD, IN THE VAST MAJORITY OF PATIENTS, IF THE PATIENT REQUIRED AN ADDITIONAL DOSE OF CONTRAST, THIS WOULD NOT HAVE A CLINICAL CONSEQUENCE. IN THE PATIENTS PREDISPOSED TO CONTRAST-INDUCED NEPHROPATHY IT IS POSSIBLE THAT AN ADDITIONAL DOSE OF CONTRAST COULD CAUSE TRANSIENT RENAL FAILURE AND IN THE WORST OF ALL CASES, TEMPORARY DIALYSIS. ABOUT 1 IN 20 PATIENTS 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 MEDICAL ADVISORY BOARD 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 MEDICAL ADVISORY BOARD ESTIMATED THAT THE RISK OF CONTRAST-INDUCED NEPHROPATHY TO A PREDISPOSED PATIENT WOULD BE ABOUT 1 IN 200,000 IF THE PHYSICIAN ELECTED TO ADMINISTER A SECOND DOSE OF CONTRAST. CORRECTIVE ACTION HAS BEEN IMPLEMENTED BY ACIST AND A RESOLUTION IS EXPECTED IN THE FIRST QUARTER 2009.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: WHILE USING THE ACIST ANGIOGRAPH CONTRAST INJECTION SYSTEM MODEL CVI WITH X-RAY INTERFACE TO SIEMENS FLUOROSCOPIC SYSTEM, DURING A LARGE INJECTION, THE DIAGNOSTIC IMAGE SEQUENCE WAS NOT COMPLETED. THERE WAS NO MEDICAL INTERVENTION NECESSARY AND NO PATIENT ADVERSE HEALTH EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1