BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER TULIP

    MDR report key: 7442637 · Received April 19, 2018

    Report

    Report Number
    7442637
    Event Type
    Death
    Date Received
    April 19, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 17, 2018
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME FOR IVC FILTER REMOVAL. CRNA BROUGHT PATIENT TO CVC IR WITH ALL STAFF WAS PRESENT AND TIMEOUT WAS COMPLETED. ONCE PROCEDURE BEGAN, PHYSICIANS INVOLVED WERE HAVING DIFFICULTY REMOVING FILTER AND TRIED MANY ATTEMPTS TO RETRIEVE. FINALLY AFTER REMOVING FILTER PHYSICIAN APPLIED DIRECT PRESSURE AND REQUESTED CVC OR TEAM TO HELP WITH CHEST TUBE PLACEMENT FOR HEMOTHORAX. PATIENT SIMULTANEOUSLY BEGAN TO DESAT IN THE 70S AND PHYSICIAN REQUESTED PATIENT BE INTUBATED. INVOLVED PARTIES CALLED OVERHEAD PAGE FOR ANESTHESIA TEAM TO ROOM STAT AS PATIENT BECAME VERY HEMODYNAMICALLY UNSTABLE. ADDITIONAL INFORMATION: DECEDENT DIED AFTER REMOVAL OF IVC FILTER. FAMILY DECLINED AUTOPSY. DEATH CERTIFICATE COMPLETED BY MEDICAL EXAMINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287931 GUNTHER TULIP FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC G52917 E3644717

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death