BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOVAC

    MDR report key: 4184679 · Received October 7, 2014

    Report

    Report Number
    2952363-2014-00009
    Event Type
    Death
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DWF
    PMA / PMN Number
    K091304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) 2014 NAVILYST MEDICAL ANGIO-VAC COMPLAINT REPORT WAS REVIEWED FOR THE FAILURE MODE "PATIENT INJURY/DEATH." NO ADVERSE TREND WAS INDICATED. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED DUE TO THE NATURE OF THE EVENT: NO DEVICE MALFUNCTION REPORTED - PATIENT ADVERSE OUTCOME. THERE WAS NO REPORTED COMPLAINT REGARDING THE PERFORMANCE OF THE ANGIOVAC DEVICE DURING THE PROCEDURE. APPROXIMATELY 1.5 HOURS INTO THE PROCEDURE, THE PATIENT EXHIBITED POOR RIGHT HEART CONTRACTILITY AND ARRESTED; CPR WAS INITIATED. THE PATIENT WAS TRANSFERRED TO ICU AND EXPIRED LATER THAT EVENING. THE ROOT CAUSE FOR THE RIGHT HEART FAILURE COULD NOT BE DETERMINED. THE DEVICE WAS NOT RETAINED SINCE THERE WAS NO DEVICE MALFUNCTION OBSERVED. THE ANGIOVAC CANNULA COMPONENT IS SUPPLIED TO NAVILYST MEDICAL BY (B)(4). (B)(4) HAS BEEN NOTIFIED OF THIS EVENT VIA SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) FOR INFORMATIONAL PURPOSES ONLY.

    Description of Event or Problem · 1

    A FILTER WAS PREVIOUSLY PLACED IN THE PATIENT'S IVC (DUE TO POTENTIAL THROMBUS IN LEGS) AND IT HAD BECOME OCCLUDED WITH DEBRIS. THE PURPOSE OF THE ANGIOVAC PROCEDURE WAS TO CLEAN OUT DEBRIS FROM THE IVC ON TOP OF THE FILTER, REMOVE THE FILTER, CLEAN OUT DEBRIS FROM THE LOWER PORTION OF THE IVC (TOWARDS THE LEGS) AND PLACE A NEW FILTER IN THE IVC. THE ANGIOVAC CANNULA WAS ON SUCTION AND THE IVC WAS CLEANED OUT ON TOP OF THE FILTER AND THE FILTER WAS REMOVED. WHILE CLEANING OUT THE LOWER PORTION OF THE IVC THE PATIENT ARRESTED (APPROXIMATELY 1.5 HOURS INTO THE PROCEDURE) AND CPR WAS INITIATED. AN IVC AND PULMONARY ANGIOGRAM PERFORMED PRIOR TO THE PATIENT ARRESTING SHOWED A NORMAL MAIN PULMONARY ARTERY (PA), I.E. NO LARGE MATERIAL IN THE MAIN PULMONARY ARTERIES. POOR RIGHT HEART CONTRACTILITY WAS OBSERVED BY THE PHYSICIAN. THERE WERE NO OBSERVED/REPORTED MALFUNCTIONS OF THE ANGIOVAC CANULA OR CIRCUIT DEVICES. THE USED DEVICES WERE DISCARDED BY THE HOSPITAL. THE PATIENT WAS TRANSFERRED TO THE ICU AND EXPIRED LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626252 ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS, INC. NA 106711-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other