BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 538823 · Received August 10, 2004

    Report

    Report Number
    2134243-2004-00007
    Event Type
    Death
    Date Received
    August 10, 2004
    Date of Event
    October 10, 2003
    Report Date
    August 9, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN AT THE USER FACILITY REPORTED A PT DEATH WHILE USING THE INJECTOR SYSTEM. REPORTEDLY A DIAGNOSTIC PROCEDURE HAD JUST BEEN COMPLETED AND, AT THE START OF AN INTERVENTIONAL PROCEDURE DURING A SMALL CONTRAST INJECTION, A SPIRAL DISSECTION OF THE CORONARY ARTERY OCCURRED AND THE PT DIED WITHIN A FEW MINUTES DESPITE RESCUE ATTEMPTS. THE USER PHYSICIAN REPORTED THAT HE DID NOT SEE IT AS A DEVICE MALFUCTION BUT A COMBINATION OF SYSTEM, CATHETER PLACEMENT, USER ERROR IN PLACING THE CATHETER TIP TOO CLOSE TO THE VESSEL WALL, AND INJECTION PRESSURE BEING TOO HIGH. NEITHER ACIST NOR THE DISTRIBUTOR WERE INFORMED OF THIS EVENT UNTIL A CLINICAL VISIT AT THE HOSP IN 7/04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CL100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death