BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS / ANGIOVAC

    MDR report key: 6326800 · Received February 13, 2017

    Report

    Report Number
    1317056-2017-00008
    Event Type
    Death
    Date Received
    February 13, 2017
    Date of Event
    January 18, 2017
    Report Date
    June 30, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWF
    UDI-DI
    H965251860
    PMA / PMN Number
    K142593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE FROM THE REPORTED EVENT WAS DISCARDED AT THE HOSPITAL (I.E., NO DEVICE EVALUATION WILL BE PERFORMED) THE INVESTIGATION INTO THIS EVENT IS ON-GOING WITH ANGIODYNAMICS' CLINICAL DEPARTMENT PERSONNEL COMMUNICATING WITH THE REPORTING PHYSICIAN TO OBTAIN ADDITIONAL EVENT DETAILS. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4). DEVICE DISCARDED AT HOSPITAL.

    Additional Manufacturer Narrative · 1

    NO REPORTED LOT NUMBER WAS PROVIDED AND A SHIP HISTORY REPORT (SHR) WAS NOT GENERATED FOR THIS COMPLAINT AS THERE WAS NO REPORT OF DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING THE PROCEDURE. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY AND THE FAILURE MODE "PATIENT INJURY / DEATH": NO ADVERSE TREND WAS IDENTIFIED. THE ANGIOVAC CANNULA WAS NOT RETURNED FOR INVESTIGATION AND IT CANNOT BE DETERMINED IF THE REDIVE WAS USED IN ACCORDANCE WITH ITS' LABELING. DIRECTIONS FOR USE PROVIDED WITH THE CANNULA INCLUDE THE FOLLOWING STATEMENTS: "WARNINGS: SELECTION OF THE PATIENT AS A CANDIDATE FOR USE WITH THIS DEVICE AND FOR SUCH PROCEDURES AS IT IS INTENDED IS THE PHYSICIANS' SOLE RESPONSIBILITY. THE OUTCOME IS DEPENDENT ON MANY VARIABLES INCLUDING, PATIENT PATHOLOGY, SURGICAL PROCEDURE, AND PERFUSION PROCEDURE/TECHNIQUE. THE BENEFITS OF USE OF THIS DEVICE MUST BE WEIGHED AGAINST THE RISKS INCLUDING RISKS OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. AS WITH ALL MEDICAL DEVICES, THIS DEVICE AND ANCILLARY EQUIPMENT ARE TO BE USED BY TRAINED PHYSICIANS ONLY. SPECIFICALLY, THIS DEVICE IS TO BE USED ONLY BY MEDICAL PERSONNEL EXPERIENCED WITH INITIATING AND MONITORING EXTRACORPOREAL BYPASS AND BY PHYSICIANS TRAINED AND EXPERIENCED USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES. ADVERSE EVENTS: THIS DEVICE, AS DO ALL EXTRACORPOREAL BLOOD VESSEL DEVICES, HAS POSSIBLE SIDE EFFECTS, WHICH INCLUDE BUT ARE NOT LIMITED TO INFECTIONS, BLOOD LOSS, THROMBUS FORMATION, EMBOLIC EVENTS, VESSEL, VENTRICULAR OR VALVULAR DAMAGE AND COMPLICATIONS OF PERCUTANEOUS OR SURGICAL INSERTION TECHNIQUES. THESE MAY OCCUR IF THE INSTRUCTIONS FOR USE ARE NOT FOLLOWED. POSSIBLE COMPLICATIONS INCLUDE THOSE NORMALLY ASSOCIATED WITH LARGE BORE SURGICAL AND/OR PERCUTANEOUS VESSEL CATHETERIZATION/CANNULATION, ANTICOAGULATION, EXTRACORPOREAL CIRCULATION AND APPLICATION OF INTRAVASCULAR INTRODUCER SYSTEMS WHICH INCLUDE BUT ARE NOT LIMITED TO: DEATH - PULMONARY EMBOLISM." (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AS REPORTED, PHYSICIAN WAS UTILIZING AN ANGIOVAC TO TREAT A RIGHT ATRIAL THROMBUS. PATIENT ADDITIONALLY HAD A PULMONARY EMBOLISM, WHICH WAS NOT BEING TREATED WITH THE DEVICE. FOLLOWING THE ANGIOVAC PROCEDURE, THE PATIENT HAD A FATAL HEART ARREST. IT WAS NOT REPORTED THAT EITHER THE DEVICE MALFUNCTIONED OR THAT USE OF THE DEVICE DURING THE PROCEDURE CONTRIBUTED TO THE OUTCOME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107969 ANGIODYNAMICS / ANGIOVAC CATHETER, CANNULA AND TUBING DWF ANGIODYNAMICS H965251860

    Patients

    Seq Age Sex Outcome Treatment
    1 Death