BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOVAC

    MDR report key: 4146987 · Received September 25, 2014

    Report

    Report Number
    2952363-2014-00008
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DWF
    PMA / PMN Number
    K091304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED, AS IT WAS DISCARDED AT THE HOSPITAL, AND NO LOT NUMBER IS AVAILABLE. THE (B)(6) 2014 NAVILYST MEDICAL ANGIOVAC COMPLAINT REPORT WAS REVIEWED FOR FAILURE MODE "PATIENT DEATH". NO ADVERSE TREND WAS INDICATED. THE ROOT CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. THE PHYSICIAN'S ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE ANGIOVAC DEVICE WAS THAT THEY ARE UNRELATED COMORBIDITY MAY BE A CONTRIBUTING FACTOR TO THE EVENT.

    Description of Event or Problem · 1

    PATIENT EXPIRED DURING ANGIOVAC PROCEDURE. AN (B)(6) OLD FEMALE ADMITTED ~ 3 WEEKS PRIOR AND RECEIVED AN ECHO WHICH VISUALIZED NO MASS OR THROMBUS. ON (B)(6) 2014 PATIENT ADMITTED TO ED WITH SOB (SHORTNESS OF BREATH) AND CHEST PAIN. RESULTING CT SHOWED A LARGE MASS IN THE RV (RIGHT VENTRICLE) AND THE RPA (RIGHT PULMONARY ARTERY), ADDITIONAL DOCUMENTATION VIA TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) AT THIS TIME. ANGIOVAC PROCEDURE ATTEMPTED ON (B)(6)2014 VIA THE RFV (RIGHT FEMORAL VEIN), WITH THE REINFUSION CANNULA PLACED LFV (LEFT FEMORAL VEIN). A 0.035' AMPLATZ SS WIRE ADVANCED TO THE RPA WITH THE GUIDANCE OF A COOK GROLLMAN CATHETER, GROLLMAN CATHETER THEN EXCHANGED FOR THE ANGIOVAC CANNULA AND OBTURATOR. ANGIOVAC CANNULA ADVANCED TO THE AREA OF THE TRICUSPID VALVE, AND AT THIS TIME ASYSTOLE WAS NOTED BY ANESTHESIA. CPR AND MEDICATIONS WERE GIVEN (BP DROPPED TO 40 SYSTOLIC), AND THE HR (HEART RATE) RETURNED TO 100 BPM, BP UP TO 80 SYSTOLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596759 ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other