BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS

    MDR report key: 6680293 · Received June 30, 2017

    Report

    Report Number
    1317056-2016-00024
    Event Type
    Death
    Date Received
    June 30, 2017
    Date of Event
    January 28, 2016
    Report Date
    July 7, 2020
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    UDI-DI
    H9656518002171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS HAS REQUESTED THAT THE HOSPITAL PROVIDE THE USED SAMPLES AND RESULTS OF THE 3RD. PARTY INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4). THE INITIAL MDR FOR THIS COMPLAINT RECORD WAS ORIGINALLY SUBMITTED ON 01/30/2016 VIA USPS. DUE TO E-SUBMITTING REQUIREMENTS, IT WAS NOT ACCEPTED. PER REQUEST, THIS INITIAL MDR REPORT IS BEING SUBMITTED VIA THE ESUBMITTER PROGRAM. THE ORIGINAL MDR HAS BEEN ATTACHED FOR REFERENCE.

    Description of Event or Problem · 1

    AS REPORTED, AIR WAS INJECTED INTO THE PATIENT DURING A CARDIAC ANGIOGRAM PROCEDURE UTILIZING AN ANGIODYNAMICS CONVENIENCE KIT. MANIFOLD WAS PREPARED IN USUAL FASHION, CONNECTIONS CHECKED AND ALL WERE SECURE. CONTRAST WAS PRIMED. AFTER TIG CATHETER INSERTION WAS CONNECTED BY MD BOTH CATHETER AND MANIFOLD FLUSHED. TWO PICTURES WERE TAKEN AND ON THE THIRD PICTURE IT WAS NOTED THAT THERE WAS AIR EMBOLI IN THE CIRCUMFLEX. PATIENT DECOMPENSATED, CODED AND DIED AFTER PROLONGED RESUSCITATION. THE USED COMPONENTS HAVE BEEN PROVIDED TO A 3RD PARTY HIRED BY THE HOSPITAL TO INVESTIGATE THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463935 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 4924376 H9656518002171

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death