BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IACIST

    MDR report key: 969378 · Received December 20, 2007

    Report

    Report Number
    2134243-2007-00014
    Event Type
    Injury
    Date Received
    December 20, 2007
    Report Date
    December 19, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: ACIST A2000 MULTI-USE SYRINGE KIT, LOT 0937G, ACIST BT2000 MANIFOLD KIT, LOT 1357J, ACIST AT-P54 HAND CONTROLLER KIT, LOTS 0397F AND 0537B. THE ACIST CONTRAST INJECTION SYSTEM WAS TAKEN OUT OF SERVICE IN 2007 AND IS BEING RETURNED TO ACIST FOR TESTING. THE DISPOSABLE KITS USED DURING THE PROCEDURE WERE DISCARDED BY THE HOSPITAL; THEREFORE, NO ANALYSIS CAN BE PERFORMED ON THESE ITEMS. THIS EVENT IS NOT CONSIDERED DEVICE-RELATED; HOWEVER, NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: DURING A RIGHT CORONARY ARTERY ANGIOGRAPHY USING THE ACIST CONTRAST INJECTION SYSTEM, AN AIR INJECTION OCCURRED AFTER THE FIRST INJECTION. THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND ABNORMAL HEART RHYTHM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L IMPLANT DATE| EXPLANT DATE| BRAND NAME 1: NI| CATALOG: NI