BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 1600676 · Received February 12, 2010

    Report

    Report Number
    2134243-2010-00001
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    December 15, 2009
    Report Date
    February 12, 2010
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INFO WAS PROVIDED TO ACIST'S MEDICAL ADVISORY BOARD FOR REVIEW. FOLLOWING IS THE MEDICAL ADVISORY BOARD ASSESSMENT DATED FEB 8, 2010: THE REPORT DESCRIBES A GUIDE CATHETER DISSECTION OF THE RIGHT CORONARY ARTERY (RCA) AT THE END OF A PCI PROCEDURE. THE PT DEVELOPED A PERICARDIAL EFFUSION. THE ACIST CONTRAST INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST (B) (4) FOR TESTING ON JAN 27, 2010. THE SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM ANALYSIS OF THE INJECTOR; HOWEVER, NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: THE USER FACILITY REPORTED AFTER COMPLETION OF AN ANGIOPLASTY, THE GUIDEWIRE WAS REMOVED, AND DURING THE CONTROL INJECTION USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, A DISSECTION OF A PT'S RIGHT CORONARY ARTERY OCCURRED WITH RAPID PERICARDIAL EFFUSION. THE PT EXPERIENCED CHEST PAIN AND ABNORMAL HEART RHYTHM. STENTING WAS DONE TO REPAIR THE DISSECTION. THE PT RECOVERED. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R CLOPIDOGREL (CLOPIDOGREL)| ASPIRINE (ACETYLSALICYLIC ACID)| FONDAPARINUX (FONDAPARINUX)