BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 2184443 · Received July 22, 2011

    Report

    Report Number
    2134243-2011-00008
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K01039
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL E2000 VOYAGER, WAS REQUESTED TO BE RETURNED TO ACIST; UPON RECEIPT OF THE INJECTION SYSTEM AT ACIST, TESTING OF THE INJECTION SYSTEM WILL BE COMPLETED. THE CONSUMABLE KITS USED DURING THE EVENT ARE NOT AVAILABLE; THEREFORE, NO ANALYSIS COULD BE MADE OF THOSE ITEMS. THE CAUSE OF DEATH IS INCONCLUSIVE AND THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY REGARDING THIS EVENT. UPON RECEIPT OF ADDITIONAL INFORMATION AND/OR COMPLETION OF TESTING OF THE INJECTOR SYSTEM, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED A PATIENT DEATH DURING AN ELECTIVE ANGIOGRAPHY. PATIENT HAD A PRIOR HISTORY OF ALLERGIES AND WAS PRETREATED WITH DIPHENHYDRAMINE. THE PATIENT DEVELOPED SLOW CORONARY FLOW IMMEDIATELY AFTER THE FIRST INJECTION OF CONTRAST. THERE WAS NO ANGIOGRAPHIC EVIDENCE OF CORONARY DISSECTION OR AIR EMBOLISM. THE PHYSICIAN PERFORMED TWO ADDITIONAL CONTRAST INJECTIONS INTO THE LEFT CORONARY. THE PATIENT RAPIDLY DEVELOPED SHOCK AND THEN VENTRICULAR FIBRILLATION; RESUSCITATION WAS UNSUCCESSFUL. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. E2000 VOYAGER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ISOVUE 370 (IOPAMIDOL) (NI)| BENADRYL (DIPHENHYDRAMINE) (NI)