BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 4071334 · Received September 3, 2014

    Report

    Report Number
    2134243-2014-00009
    Event Type
    Death
    Date Received
    September 3, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST ON (B)(4) 2014, FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. A COPY OF THE CINE-ANGIOGRAM AND THE ACIST CONSUMABLE KITS WERE REQUESTED BY ACIST, BUT THE USER FACILITY ELECTED NOT TO PROVIDE THESE ITEMS. THE ACIST CONTRAST INJECTION SYSTEM IS EQUIPPED WITH AN AIR COLUMN DETECT SENSOR. THE AIR COLUMN DETECT SENSOR SENSES AIR IN THE PROXIMAL END OF THE HIGH -PRESSURE (INJECTION) TUBING. IF AIR IS DETECTED IN THE TUBING, ALL FLUID DELIVERY FUNCTIONS ARE DISABLED. PER THE ACIST CVI USERS MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM. BASED ON THE TESTING OF THE INJECTOR, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT. THIS CAUSE OF THE EVENT IS INCONCLUSIVE. ACIST'S CLINICAL APPLICATION SPECIALIST PROVIDED FOLLOW-UP IN-SERVICE TRAINING TO THE HOSPITAL STAFF. THIS WAS COMPLETED ON (B)(6) 2014. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: AIR WAS INJECTED INTO A PT ON THE FIRST INJECTION OF CONTRAST MEDIA INTO THE LEFT CORONARY ARTERY (LCA). THE CATHETER WAS ASPIRATED UNTIL BLOOD WAS SEEN WITH A SYRINGE AND THEN THE CATHETER WAS FLUSHED WITH SALINE. AFTER THE FIRST INJECTION OF CONTRAST MEDIA INTO THE PT, THE PT'S LCA HAD A COMPLETE CESSATION OF FLOW RESULTING IN IMMEDIATE HEMODYNAMIC INSTABILITY AND NECESSITY FOR CPR. THE PT EXPERIENCED BRADYCARDIA FOR A DURATION OF APPROXIMATELY 30 MINUTES, HYPOTENSION, AND EVIDENCE OF MYOCARDIAL INFARCTION. THE AIR WAS VISUALIZED ON THE FIRST ANGIOGRAM. TO STABILIZE THE PT, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INSERTED THROUGH THE FEMORAL ACCESS. REPEAT ANGIOGRAMS SHOWED NORMALIZED FLOW IN THE LEFT CIRCUMFLEX ARTERY (LCX) WHILE THERE WAS STILL THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) I-II FLOW IN THE PERIPHERAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AT THE END OF THE PROCEDURE. THE PT RECEIVED THERAPEUTIC HYPOTHERMIA FOR 36 HOURS AND REMAINED ON ECMO. SIGNIFICANT IMPROVEMENT IN LEFT VENTRICULAR (LV) FUNCTION WAS OBSERVED UNTIL (B)(6) 2014. THE MORNING OF (B)(6) 2014, THE PT SHOWED SIGNS OF WAKING UP AFTER REDUCED SEDATION. SUBSEQUENTLY, DURING WASHING/POSITIONING OF THE PT, THE ARTERIAL CANNULA OF THE ECMO IN THE LEFT FEMORAL ARTERY SLIPPED OUT AND DISLOCATED INTO THE QUADRICEPS, RESULTING IN SEVERE HEMORRHAGE INTO THE THIGH AND HEMORRHAGIC SHOCK. DESPITE RAPID INSERTION OF A NEW ARTERIAL CANNULA ON THE LEFT SIDE, THE PT DID NOT RECOVER FROM THIS EVENT AND DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535905 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death METOHEXAL| NORVASC| SPIRIVA| XARELTO| PENICILLIN| L-THYROX