BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFETRAC DUAL WIRE INSERTION KIT

    MDR report key: 493254 · Received October 31, 2003

    Report

    Report Number
    1223643-2003-00006
    Event Type
    Death
    Date Received
    October 31, 2003
    Date of Event
    September 26, 2003
    Report Date
    October 31, 2003
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF BEING SHORT OF BREATH AND SOON APPEARED TO BE IN SUDDEN CARDIAC ARREST AND EXPIRED DURING CATHETERIZATION. THERE WAS NO EVIDENCE ON FLUOROSCOPY OF PNEUMOTHORAX OR ANY IRREGULARITIES. FOLLOWING THE CODE, A CHEST X-RAY AND ECHOCARDIOGRAM WERE PERFORMED AND THERE WAS NO EVIDENCE OF IRREGULARITIES CAUSED FROM CATHETER INSERTION. FOLLOW-UP CONVERSATIONS BETWEEN DISTRIBUTOR REP AND DR. INDICATE THAT THE DR DOES NOT BELIEVE THE PROCEDURE WAS A DIRECT RESULT OF THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETRAC DUAL WIRE INSERTION KIT CATHETERIZATION KIT DYB SPIRE BIOMEDICAL, INC. XDWIK28 99357994

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death