BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 689909 · Received March 13, 2006

    Report

    Report Number
    1118880-2006-00008
    Event Type
    Death
    Date Received
    March 13, 2006
    Date of Event
    January 19, 2006
    Report Date
    February 13, 2006
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "THE CONNECTION OF THE FLUSH BAG TO THE 3 WAY LUER LOCK OF THE SHEATH, THE FLUSH BAG WAS FOUND DISCONNECTED RESULTING IN HEMORRHAGE RESULTING IN DEATH." THE USER FACILITY MEDWATCH REPORT NUMBER HAS BEEN REQUESTED SEVERAL TIMES, BUT HAS NOT BEEN RECEIVED. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY RESULTED IN ADD'L INFO BEING REC'D IN MARCH 2006, WHICH STATED: "PT WAS 2.5 HOURS POST PCI/STENT AWAITING SHEATH REMOVAL. PT IN RECOVERY ROOM, AWAITING ACT TO COME DOWN TO <160 SECONDS FOR SHEATH REMOVAL POST PCI. PT ARRIVED IN RECOVERY ROOM 1307 HRS AND VS AND GROIN CHECK WAS PERFORMED AT 1515 HRS, AND AT 1530 HRS SHEATH FOUND DISCONNECTED FROM HEPARIN FLUSH BAG AND BLEEDING NOTED, STOPCOCK ON SHEATH TURNED OFF TO THE PT AND BLEEDING STOPPED." REPORTEDLY, FLUIDS AND DOPAMINE WERE ADMINISTERED, TRANSFUSION WAS INITIALLY REFUSED FOR RELIGIOUS REASONS, BUT CONSENT WAS EVENTUALLY OBTAINED. THE USER FACILITY DISCHARGE SUMMARY STATES: "DESPITE 2 UNITS OF PACKED RED BLOOD CELLS AND APPROX 3 UNITS OF SALINE, BLOOD PRESSURE REMAINED LOW. EKG SHOWED SINUS RHYTHM AT 89 BEATS PER MINUTE WITH NEW RIGHT BUNDLE BRANCH BLOCK. AFTER PROLONGED ATTEMPTS WERE MADE FOR RESUSCITATION, WHICH FAILED, PT WAS DECLARED EXPIRED AT 5:40 P.M."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS INTRODUCER II KIT INTRODUCER, CATHETER DYB TERUMO MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *