BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 1882559 · Received October 22, 2010

    Report

    Report Number
    2520313-2010-00035
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 23, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE AVANTA INJECTOR, PERFORMED ON SEPTEMBER 24, 2010, VERIFIED THE INJECTOR IS OPERATING WITHIN MEDRAD SPECIFICATIONS. THE SITE CONTINUED TO USE THE INJECTOR AFTER THE REPORTED EVENT. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED ON SEPTEMBER 23, 2010. THE SITE INDICATED THAT THEY DID NOT RETAIN THE DISPOSABLES THAT WERE IN-USE DURING THE REPORTED EVENT. THE BATCH NUMBERS WERE NOT PROVIDED FOR THE DISPOSABLES; THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE. AT THIS TIME, THE UNDERLYING CAUSE OF THE EMBOLISM OR AIR INJECTION AND IT'S RELATEDNESS TO THE AVANTA INJECTOR IS INCONCLUSIVE. HOWEVER, THE CAUSE OF THE PATIENT'S EMBOLISM OR AIR INJECTION AS POSSIBLY RELATED TO THE AVANTA INJECTOR CANNOT BE CONCLUSIVELY RULED OUT AND THUS THIS EVENT IS CONSIDERED REPORTABLE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PATIENT WITH AN ADMITTING DIAGNOSIS OF CHEST PAIN WAS UNDERGOING A CARDIAC CATHERIZATION AND CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY. POST BALLOON DILATATION AND STENT DEPLOYMENT OF THE LEFT ANTERIOR DESCENDING ARTERY, SLOW FLOW WAS NOTED ON THE ANGIOGRAM. THE PATIENT RECEIVED INTRACORONARY CALAN FOR SLOW FLOW, INTRAVENOUS INTEGRILIN FOR SLOW FLOW, AND INTRAVENOUS ATROPINE FOR BRADYCARDIA. THE PATIENT BECAME HYPOTENSIVE AND THE BRADYCARDIA WAS NOT RESPONDING TO ATROPINE. AN INTRA-AORTIC BALLOON PUMP AND A TEMPORARY PACEMAKER WERE INSERTED. ADDITIONALLY, THE PATIENT'S SEDATION HAD TO BE REVERSED DUE TO DECREASED LEVEL OF CONSCIOUSNESS. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. THE MOST RECENT INFORMATION THAT WE RECEIVED INDICATED THAT THE PATIENT WAS EXTUBATED AND DISCHARGED TO THE STEP DOWN UNIT. POST PROCEDURE, THE PHYSICIANS INVOLVED WITH THE CASE REVIEWED THE ANGIOGRAMS AND CONCLUDED THAT THIS EVENT WAS CAUSED BY EITHER AN EMBOLISM OR AN AIR INJECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R AVANTA MULTI-PATIENT DISPOSABLE SET| AVANTA SINGLE-PATIENT DISPOSABLE SET