BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS / ANGIOVAC

    MDR report key: 6424653 · Received March 22, 2017

    Report

    Report Number
    1317056-2017-00030
    Event Type
    Death
    Date Received
    March 22, 2017
    Date of Event
    February 26, 2017
    Report Date
    March 22, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO UPN OR LOT NUMBER WAS PROVIDED BY THE HOSPITAL, A SHIP HISTORY REPORT / DEVICE HISTORY REVIEW WAS UNABLE TO BE CONDUCTED. THE JANUARY 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY AND THE FAILURE MODE, "PATIENT INJURY / DEATH." NO ADVERSE TREND WAS IDENTIFIED. ALTHOUGH THE DEVICE USED IN THE REPORTED EVENT WAS DISCARDED AT THE HOSPITAL AND WAS UNAVAILABLE FOR EVALUATION, THE INFORMATION PROVIDED BY THE END USER INDICATES THAT THE DEVICE PERFORMED PROPERLY DURING THE PROCEDURE AND DID NOT CONTRIBUTE TO THE PATIENT'S SUBSEQUENT DEATH. ((B)(4)). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE WITH ONE WEEK HISTORY OF ABDOMINAL PAIN, CT ANGIOGRAPHY REVEALED EXTENSIVE THROMBOSIS OF HIS IVC EXTENDING FROM HIS ILIAC VEIN TO NEAR THE HEPATIC VEIN. HE WAS ALSO NOTED TO BE IN ACUTE RENAL FAILURE WITH A CREATININE OF 1.9. PATIENT WAS TRANSFERRED FROM ANOTHER FACILITY FOR AN EMERGENT ANGIOVAC PROCEDURE. PROCEDURE STARTED AT ABOUT NOON. PATIENT WAS STABLE DURING THE PROCEDURE. FOUR FILTERS OF MATERIAL WAS REMOVED. VENOGRAM POST PROCEDURE SHOWED AN IMPROVED APPEARANCE OF THE IVC, ILIAC AND FEMORAL VEIN WITH FLOW. CASE CONCLUDED, PATIENT WAS STABLE AND TRANSFERRED OUT ON HEPARIN. PATIENT'S HEMODYNAMICS AT ONSET OF PROCEDURE (STABLE, UNSTABLE, CRITICAL). STABLE AWAKE AND TALKING. ACCESS SITES: RIGHT IJ FOR ANGIOVAC AND RETURN RIGHT FEMORAL VEIN. LEFT FEMORAL VEIN WAS ACCESSED FOR ADJUNCTIVE DEVICES. ADJUNCTIVE DEVICES AND HOW WERE THEY USED: CLEANER WIRE VIA LEFT FEMORAL VEIN USED IN THE IVC AND DISTALLY. DURATION OF CASE: APPROXIMATELY 5 HOURS. THE CASE CONCLUDED AT ABOUT 4:15 PM ON (B)(6) AND ANGIODYNAMICS' SALES REPRESENTATIVE WAS NOTIFIED AT 10:00 AM ON (B)(6) THAT THE PATIENT HAD EXPIRED. DR (B)(6) STATED THAT DURING THE NIGHT THE PATIENT WAS COMPLAINING OF UPPER ABDOMINAL PAIN, WAS BEING TRANSPORTED AND CODED AND EXPIRED. PHYSICIAN SUSPECTED A PE. THE PHYSICIAN DID NOT INDICATE THAT THERE WAS ANY MALFUNCTION WITH THE EQUIPMENT. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206004 ANGIODYNAMICS / ANGIOVAC CARDIOPULMONARY BYPASS PUMP DWE ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death