BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1870720 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00719
    Event Type
    Death
    Date Received
    October 8, 2010
    Date of Event
    September 5, 2010
    Report Date
    October 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A "SEPTIC" PT. WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED INTO THE PATIENT'S GROIN. THE MD COULD NOT INSERT THE IAB THROUGH THE SAF SHEATH. AS A RESULT, THE MD REMOVED THE IAB AND SHEATH AS ONE UNIT. THE MD INSERTED A 10 FRENCH SHEATH TO CONTROL THE BLEEDING. ADDITIONAL INFO RECEIVED ON 10/01/2010 FROM THE SALES REP STATED THAT "THE PHYSICIAN WAS CONCERNED THAT WHEN HE REMOVED THE IAB AND SHEATH THAT HE ENLARGED THE HOLE. THAT IS WHY THE MD PLACED A LARGER (10 FRENCH) SHEATH. IT DIDN'T BLEED AFTER THE SHEATH WAS INSERTED." THE PT WAS STABILIZED WITH MEDS AND TRANSFERRED TO THE UNIT WITHOUT IAB SUPPORT. THE PT PASSED AWAY THE NEXT DAY.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death