BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIACCESS SYSTEM

    MDR report key: 6413352 · Received March 17, 2017

    Report

    Report Number
    3011300266-2017-00001
    Event Type
    Death
    Date Received
    March 17, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 15, 2017
    Manufacturer
    EPIEP, INC.
    Product Code
    DYB
    PMA / PMN Number
    K142245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE EPIACCESS SYSTEM WAS USED TO TRY TO GAIN PERICARDIAL GUIDE WIRE ACCESS FOR A PLANNED VT ABLATION. PERICARDIAL ACCESS FAILED SUGGESTING THE PRESENCE OF ADHESIONS IN THE PERICARDIAL SPACE. THE PLANNED VT ABLATION PORTION OF THE PROCEDURE WAS THEN ABORTED AS THE ELECTROPHYSIOLOGIST WAS UNABLE TO GAIN PERICARDIAL GUIDE WIRE ACCESS. THE PATIENT WAS THEN NOTED TO HAVE A CONSISTENT DECLINE IN THE BLOOD PRESSURE WITH EVENTUAL SIGNIFICANT HYPOTENSION (SBP 60-70MMHG) ONLY MILDLY RESPONSIVE TO HEMODYNAMIC SUPPORT WITH VASOPRESSORS AND INOTROPES. A TRANSESOPHAGEAL ECHO (TEE) WAS PERFORMED, WHICH SHOWED ACCUMULATION OF FLUID IN THE INTRA-ABDOMINAL CAVITY. EXPLORATIVE SURGERY WAS PERFORMED AND IT WAS DETERMINED TO BE SECONDARY TO A PERFORATION ON THE INFERIOR SURFACE OF THE RIGHT VENTRICLE COMMUNICATING WITH THE ABDOMINAL CAVITY VIA A TRACK IN THE DIAPHRAGM. THE PERFORATION WAS REPAIRED, HOWEVER, THE PATIENT'S CONDITION CONTINUED TO WORSEN AND FAILED TO RESPOND TO AGGRESSIVE RESUSCITATIVE MEASURES INCLUDING BLOOD TRANSFUSION AND OPEN CARDIAC MASSAGE RESULTING IN EXPIRATION. THE CASE WAS A DIFFICULT EPICARDIAL ACCESS CASE BECAUSE THE PATIENT HAD BEEN PREVIOUSLY TREATED, AND HAD PERICARDIAL ADHESIONS ACCORDING TO THE TREATING PHYSICIAN. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE ATTENDING PHYSICIAN DOES NOT ATTRIBUTE THE ADVERSE EVENT (RV PUNCTURE) TO THE EPIACCESS SYSTEM, BUT RATHER AS A RESULT OF THE PATIENT ANATOMY AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195423 EPIACCESS SYSTEM EPICARDIAL INTRODUCER SYSTEM DYB EPIEP, INC. 0399-13950 20927

    Patients

    Seq Age Sex Outcome Treatment
    1 Death