BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOVAC

    MDR report key: 3998983 · Received August 5, 2014

    Report

    Report Number
    2952363-2014-00007
    Event Type
    Death
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DWF
    PMA / PMN Number
    K091304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO DEVICE IS BEING RETURNED FOR EVALUATION, THE INVESTIGATION INTO THIS EVENT IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED BASED ON A SHIP HISTORY REPORT (SHR) OBTAINED FROM (B)(4) (THE SUPPLIER), THE REPORTING HOSPITAL ONLY RECEIVED 2 PACKAGING LOTS WITHIN THE SIX MONTHS PRIOR TO THE REPORTED PROCEDURE DATE. THE ANGIOVAC CANNULA COMPONENT IS SUPPLIED TO ANGIODYNAMICS BY THE SUPPLIER (B)(4) WAS BEEN NOTIFIED VIA SUPPLIER CORRECTIVE ACTION REQUEST FOR A DEVICE HISTORY RECORDS REVIEW OF THE SUPPLIER LOT. ALL MANUFACTURING RECORDS WERE FOUND TO BE COMPLETED AND IN ORDER. THERE WERE NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY AND THE FAILURE MODE "PATIENT INJURY/DEATH. " NO ADVERSE TRENDS WERE IDENTIFIED. THE HOSPITAL DID NOT REPORT A DEVICE MALFUNCTION AND THERE IS NO INDICATION THAT THERE WAS A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT (PATIENT DEATH). THE ANGIOVAC CANNULA SAMPLE WAS NOT RETURNED FOR EVALUATION SINCE THERE WAS NO REPORTED DEVICE FAILURE. IT CANNOT BE DETERMINED IF THE CANNULA WAS USED IN ACCORDANCE WITH ITS LABELING. DIRECTIONS FOR USE ARE PROVIDED WITH THIS DEVICE AND CONTAINS THE FOLLOWING STATEMENTS: "ADVERSE AFFECTS: 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 DAMAGE AND COMPLICATIONS OF PERCUTANEOUS OR SURGICAL INSERTION TECHNIQUES. THESE MAY OCCUR IF THE INSTRUCTIONS FOR USE ARE NOT FOLLOWED." NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS VERY SICK WITH A BILATERAL PULMONARY EMBOLISM. PRIOR TO THE PROCEDURE AN ECHO AND PA GRAM SHOWED THAT THE RIGHT VENTRICLE WAS BARELY FUNCTIONING. THE PATIENT HAD STAGE 4 CANCER AND HAD DO NOT RESUSCITATE (DNR) STATUS, HOWEVER, THE PATIENT DID WANT TO TRY THE ANGIOVAC PROCEDURE. THE PATIENT WAS TAKEN OFF DNR IN ORDER TO HAVE THE PROCEDURE, BUT THE PHYSICIAN DID NOT WANT TO USE ECMO (HEART/LUNG BYPASS MACHINE). "THE PATIENT WAS GRAY IN COLOR BUT TALKING DURING THE PROCEDURE. ONCE THE PUMP (PERFUSION) WAS ON NO MORE THAN ONE MINUTE, THE PATIENT STARTED TO CRASH. CPR WAS PERFORMED, VOLUME WAS GIVEN. ALL LIFE SAVING MEASURES WERE PERFORMED BUT TO NO AVAIL." THE USED ANGIOVAC CANNULA WAS DISCARDED AT THE HOSPITAL. PER ANGIODYNAMICS CLINICAL SPECIALIST PRESENT DURING THE PROCEDURE, THERE WAS NO MALFUNCTION OF THE DEVICE, AND NO ISSUES WITH PHYSICIAN TECHNIQUE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455895 ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death