BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 538818 · Received August 10, 2004

    Report

    Report Number
    2134243-2004-00008
    Event Type
    Other
    Date Received
    August 10, 2004
    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 THE OCCURRENCE OF A SPIRAL DISSECTION OF THE PT'S RCA DURING A DIAGNOSTIC PROCEDURE WHILE USING THE INJECTOR SYSTEM. INTERVENTION WAS REQUIRED WITH THE PLACEMENT OF STENTS AND THE PT RECOVERED WITHOUT FURTHER SEQUELAE. THE USER PHYSICIAN REPORTED THAT HE DID NOT SEE IT AS A DEVICE MALFUNCTION 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. THE PHYSICIAN INDICATED THE EVENT HAD OCCURRED APPROXIMATELY TWO MONTHS BEFORE THE VISIT, THEREFORE AN ESTIMATED OCCURRENCE DATE OF 5/04.

    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 * Other