BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 536129 · Received July 20, 2004

    Report

    Report Number
    2134243-2004-00005
    Event Type
    Other
    Date Received
    July 20, 2004
    Date of Event
    June 17, 2004
    Report Date
    July 19, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AIR WAS INJECTED INTO A PT DURING A DIAGNOSTIC STUDY OF THE LEFT CORONARY ARTERY. THE PT WAS SENT TO THE ICU FOR FURTHER EVALUATION. USER FACILITY RISK MANAGEMENT REPORTED THAT THE PT DID NOT SUSTAIN INJURY TO THE EXTENT THAT REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening| R