BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTROFLEX PERCUTANEOUS SHEATH INTRODUCER

    MDR report key: 642792 · Received October 19, 2005

    Report

    Report Number
    6000002-2005-00577
    Event Type
    Death
    Date Received
    October 19, 2005
    Date of Event
    September 18, 2005
    Report Date
    September 29, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN 2005 PT IN ICU WAS FOUND TO HAVE EXCESSIVE BLEEDING FROM RIJ LARGE BORE INTRODUCER. PT SUSTAINED EXTENDED ASYSTOLIC/PEA ARREST. RESUSCITATION LASTED OVER 1 HR AND REQUIRED 13 LITERS OF FLUID AND 4 UNITS OF PRBC. PT REGAINED PULSE AND WENT EMERGENTLY TO THE OR AND THEN SICU. PT WAS REMOVED FROM LIFE SUPPORT 4 DAYS LATER. FOLLOWUP INDICATED THAT INTRODUCER SEPARATED FROM B. BRAUN MEDICAL PUMP. HOSP IS NOT ATTRIBUTING PT'S EXPIRATION TO INTRODUCER. DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROFLEX PERCUTANEOUS SHEATH INTRODUCER INTRODUCER DYB EDWARDS LIFESCIENCES I505BF9C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death