BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR -40 CC FOS

    MDR report key: 1725451 · Received June 11, 2010

    Report

    Report Number
    1219856-2010-00388
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 22, 2010
    Report Date
    June 10, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION; PULLED VACUUM, HELD VACUUM WHILE ADVANCING THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH WHICH WAS INSERTED IN THE PTS' RIGHT FEMORAL ARTERY. THE "IAB BECAME STUCK IN THE SAF SHEATH IN THE END." THE MD REMOVED THE IAB AND THE SHEATH. THE MD REQUESTED ANOTHER IAB FOR INSERTION. THE SECOND IAB WAS INSERTED SUCCESSFULLY. PER THE REPORT THERE WAS NO DELAY IN THERAPY. THERE WAS NO REPORTED MEDICAL OR SURGICAL INTERVENTION REQUIRED. ACCORDING TO THE REPORTER THE PT OUTCOME IS "OK AT THE MOMENT, BUT UNSTABLE." ADDITIONAL INFO RECEIVED FROM THE SALES REP ON 06/01/2010 STATED THAT THE PT PASSED AWAY "LATER ON AND THE DEATH WAS NOT RELATED TO THE IAB." THE PT DIED DUE TO HEART FAILURE, PER THE HEAD RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR -40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF9067740

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death