BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1805297 · Received August 13, 2010

    Report

    Report Number
    1219856-2010-00517
    Event Type
    Death
    Date Received
    August 13, 2010
    Date of Event
    July 18, 2010
    Report Date
    August 12, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CORONAROGRAPHY UNIT, THE MD INSERTED A SUPER ARROW-FLEX (SAF) SHEATH INTO THE PT'S FEMORAL ARTERY. AS THE INTRA-AORTIC BALLOON (IAB) WAS BEING INSERTED INTO THE SHEATH, THE IAB BECAME STUCK. THE MD REMOVED THE IAB AND THE SHEATH AS ONE UNIT. ANOTHER KIT WAS REQUESTED BY THE MD. IAB WAS PREPPED AND THE FIBEROPTIX SENSOR (FOS) SLIDE WAS INSERTED INTO THE PUMP, HOWEVER, THE FOS WAS NOT RECOGNIZED BY THE PUMP. AS A RESULT, THE IAB WAS USED "IN AUTOMATIC MODE." ADDITIONAL INFORMATION RECEIVED ON 07/28/2010 FROM THE SALES REP STATED "THE PT DIED ON (B)(6) 2010 BUT THE CARDIOLOGIST CERTIFIES THAT THERE IS NO LINK BETWEEN THE INCIDENT AND THE DEATH."

    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. MF0021583

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death