BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT FLUID SYSTEM

    MDR report key: 3528009 · Received December 17, 2013

    Report

    Report Number
    2520313-2013-00070
    Event Type
    Death
    Date Received
    December 17, 2013
    Date of Event
    October 25, 2013
    Report Date
    November 25, 2013
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A BAYER R & I SERVICE PERFORMED AN INJECTOR CHECKOUT OF THE AVANTA FLUID MANAGEMENT SYSTEM AND CONFIRMED THE INJECTOR PERFORMED TO SPEC. THE DISPOSABLE FROM THE ALLEGED INCIDENT WERE DISCARDED AND NOT AVAILABLE FOR EVAL. THE SITE PROVIDED THE LOT NUMBER OF THE SINGLE-PT DISPOSABLE SET (SPAT) THAT WAS IN USE DURING THE ALLEGED INCIDENT. BAYER R & I QUALITY ASSURANCE PRODUCT ANALYSIS EXAMINED A RETAINED SPAT SAMPLE FROM LOT NUMBER 132201. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED - THE PRODUCT PERFORMED TO SPEC. THE AVANTA FLUID MANAGEMENT SYSTEM HAS BEEN IN USE DAILY AT THE SITE SINCE THE REPORTED OCCURRENCE. ADD'L APPLICATION TRAINING WAS PERFORMED ON (B)(4) 2013.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING TO A BAYER R & I REP: (B)(6) MALE PT WITH A HISTORY OF A MYOCARDIAL INFARCTION UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA) AND SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM. THE PT WAS REPORTED TO BE STABLE AFTER THE ALLEGED AIR INJECTION. DURING STENT PLACEMENT, THE STENT DISLOCATED FROM THE BALLOON WITHOUT EXPANDING. THE SITE ATTEMPTED TO RETRIEVE THE STENT, HOWEVER, DURING THEIR RETRIEVAL EFFORTS THE AORTA DISSECTED AND THE PT BECAME UNSTABLE. THE PT WAS TREATED WITH CARDIOPULMONARY RESUSCITATION (CPR) AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PT WAS IMMEDIATELY SENT TO SURGERY AND DIED 2 DAYS FOLLOWING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658812 AVANTA FLUID MANAGEMENT FLUID SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD AVA 500 TABL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death