BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUETT

    MDR report key: 353514 · Received September 11, 2001

    Report

    Report Number
    353514
    Event Type
    Death
    Date Received
    September 11, 2001
    Date of Event
    August 31, 2001
    Report Date
    September 11, 2001
    Manufacturer
    VASCUALR SOLUTIONS INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2001: 10:52: PT ADMITTED TO CARDIOVASCULAR LAB FOR HEART CATHETERIZATION. 11:30: DUETT DEPLOYED (MODEL #1000, LOT #300348). 11:44: PT COMPLAINED OF NAUSEA AND DYSPNEA. 11:45: DR NOTIFIED (IN CATH, VIEWING ROOM) WITH IMMEDIATE RESPONSE TO CARDIOVASCULAR LAB (CVL), CVL TECH STATED PT WAS SHORT OF BREATH, PT HAD REDDISH HUE OVER THE UPPER TORSO, BOTH LOWER EXTREMITIES, AND, IMMEDIATELY, DR FELT THE PT HAD A DUETT CLOSURE DEVICE SYSTEMIC ALLERGIC REACTION. RESUSCITATIVE EFFORTS WERE INITIATED INCLUDING: INTUBATION/VENTILATION, EXTERNAL PACER, IV FLUID, IV ATROPINE, IV SOLUMEDROL, IV BENADRYL, IV EPINEPHRINE AND IV DOPAMINE, IV LASIX, IV ALBUMIN. 12:35: BLOOD PRESSURE WAS NOT SUSTAINED. PROCEDURE TERMINATED. THE PT WAS WITHOUT BLOOD PRESSURE, SPONTANEOUS RESPIRATIONS, OR HEARTBEAT. PRONOUNCED DECEASED AT 12:35. PER CARDIOVASCULAR LABORATORY REPORT OF PROCEDURE: COMPLICATION: "ALLERGIC REACTION TO DUETT (THROMBIN) REQ. INTUBATION AND DEATH SECONDARY TO ANAPHYLAXIS-MASSIVE". PER DISCHARGE NOTE: "FELT PT WAS HAVING AN ANAPHYLACTIC REACTION TO THE DUETT DEVICE, SPECIFICALLY THROMBIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41286 DUETT COMPLETE SEALING DEVICE MGB VASCUALR SOLUTIONS INC. 1000 300348

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death 7 F JL4, USCI-MEDTRONIC, 010360,| INVENTORY ITEM: 8 F SHEATH, VENDOR NAME:| CONTRAST, BENADTYL IV, VALIUM IV.| 8 F SHEATH, USCI-MEDTRONIC, 080011,| 7 F PIG, USCI-MEDTRONIC, 010355,| UTILIZED DURING HEART CATHETERIZATION, OMNIPAQUE| 7 F SWAN GANZ MONITOR, BAXTER, 111F7P,| USCI-MEDTRONIC, VENDOR PN: 080011,| J F AR 1, USCI-MEDTRONIC, 009230.