BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 1343844 · Received March 12, 2009

    Report

    Report Number
    2134243-2009-00002
    Event Type
    Injury
    Date Received
    March 12, 2009
    Date of Event
    February 5, 2009
    Report Date
    March 10, 2009
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2009, ACIST'S MEDICAL ADVISORY BOARD MEMBER CONTACTED THE HOSPITAL'S CHARGE TECHNOLOGIST - RADIOLOGY AND DISCUSSED THE EVENT. PER THIS DISCUSSION, ACIST'S MEDICAL ADVISORY BOARD MEMBER AND THE HOSPITAL'S CHARGE TECHNOLOGIST - RADIOLOGY STATE THAT THE ROOT CAUSE OF THE EVENT IS CATHETER-RELATED DISSECTION. ALTHOUGH THERE IS NO EVIDENCE OF MALFUNCTION OF THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, THE INJECTION SYSTEM IS REQUESTED TO BE RETURNED TO ACIST FOR TESTING, PER ACIST'S STANDARD PROCEDURE. THE CVI INJECTION SYSTEM HAS BEEN IN USE AT THE HOSPITAL SINCE THE EVENT OCCURRED. THE ACIST STERILE DISPOSABLE KITS WERE REQUESTED TO BE RETURNED BUT DUE TO THE ONE-MONTH LAPSE BETWEEN THE EVENT AND THE REPORT TO ACIST, THESE HAD ALREADY BEEN DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI AND A BOSTON SCIENTIFIC ROTABLATOR GUIDEWIRE, A DISSECTION OF A PATIENT'S CORONARY ARTERY AND AORTA (PROXIMAL/MID RIGHT CORONARY ARTERY TO AORTIC BIFURCATION) OCCURRED. THE PATIENT'S BLOOD PRESSURE FELL TO BELOW 90 MMHG SYSTOLIC AND THERE WAS EVIDENCE OF MYOCARDIAL INFARCTION. STENTING WAS DONE TO REPAIR THE DISSECTION AND THE PATIENT WAS PLACED ON A VENTILATOR. THE PATIENT REMAINED HOSPITALIZED AT THE TIME THE EVENT WAS REPORTED TO ACIST IN 2009. AS OF EIGHT DAYS LATER, THE PATIENT HAS RECOVERED. THE HOSPITAL'S CHARGE TECHNOLOGIST - RADIOLOGY REPORTED THAT THE CAUSE OF THE EVENT WAS CATHETER-INDUCED DISSECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R GALAXY IVUS - ATLANTIS SR PRO 40 MHZ| BOSTON SCIENTIFIC ROTOBLATOR GUIDEWIRE 6 FR| DATASCOPE CARDIAC ASSIST LINEAR BALLOON CATHETER| MEDTRONIC DRIVER CORONARY BARE METAL STENT| NITROGLYCERINE| MIRINONE| HEPARIN| PROPOFOL| CORDIS CYPHER DRUG-ELUTING STENT| LIDOCAINE