BEUDAMED
    FDA Adverse Event Death Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 2130071 · Received June 16, 2011

    Report

    Report Number
    2134265-2011-02521
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA OR 510(K) # - K050964. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-02520, 2134265-2011-02522. IT WAS REPORTED THAT POST AN EMBOLIZATION TREATMENT PROCEDURE FOR A LIVER LACERATION, THE PATIENT EXPIRED. THE PATIENT PRESENTED UNSTABLE WITH A LIVER LACERATION AND LOSING BLOOD PRESSURE DUE TO TRAUMA. A RENEGADE HI FLO CATHETER WAS USED WITH A TRANSCEND GUIDE WIRE AND A FATHOM GUIDE WIRE TO PERFORM THE EMBOLIZATION. THE DEVICES WERE USED SUCCESSFULLY TO TREAT THE LIVER LACERATION. NO BLEED WAS FOUND IN THE SPLENIC ARTERY. POST THE EMBOLIZATION, THE PATIENT DID NOT STABILIZE. THE PHYSICIAN CONSIDERED THAT THE PATIENT HAD ANOTHER UNDERLYING INJURY. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY AND EXPIRED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FATHOM GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - FREMONT UNK171

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RENEGADE HI FLO CATHETER