BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1938689 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00912
    Event Type
    Death
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2010-00911 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE HOSPITAL REPORTED AN INCIDENT INVOLVING A PT IN THE CARDIOVASCULAR DEPT. THE INTRA-AORTIC BALLOON (IAB) WAS BEING ADMINISTERED FOR ISCHEMIA AND CARDIAC FAILURE. THE MD INSERTED THE IAB VIA THE SUPER ARROW-FLEX (SAF) SHEATH IN THE LEFT FEMORAL ARTERY. THE IAB STOPPED AND COULD NOT BE ADVANCED FORWARD OR BACK. THE MD REMOVED THE IAB AND SHEATH TOGETHER. THE PT WAS IN CRITICAL CONDITION WITH PERSISTENT CARDIOGENIC SHOCK; DESPITE AORTOCORONARY BRIDGING, SHE EXPIRED. ADD'L INFO RECEIVED ON 12/20/2010 STATED THE PROFESSOR INFORMED THE SALES REP FOR THE DISTRIBUTOR THAT THIS PT WAS NOT LIKELY TO HAVE SURVIVED EVEN WITH IAB THERAPY. THE PT WAS VERY ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death NOREPINEPHRINE