BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR -40 CC FOS

    MDR report key: 1725456 · Received June 11, 2010

    Report

    Report Number
    1219856-2010-00392
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 29, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REF MDR #1219856-2010-00391 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE SECOND INTRA-AORTIC BALLOON (IAB) BECAME STUCK IN THE SUPER ARROW-FLEX (SAF) SHEATH DURING INSERTION. THE INSERTION ANATOMICAL INSERTION SITE IS NOT AVAILABLE. THE MD REMOVED THE IAB AND THE SAF SHEATH. THE MD "UP SIZED TO A 9 FR. SHEATH AND THE THIRD IAB WAS INSERTED INTO THE PT." A PT DEATH WAS REPORTED. THERE IS NO INFO AVAILABLE IN REF TO THE QUESTION "DID THE DEVICE CAUSE OR CONTRIBUTE TO THE PT'S DEATH?" THERE IS NO AVAILABLE INFO IN REF TO THE QUESTION "WAS MEDICAL/SURGICAL INTERVENTION REQUIRED?" BASED ON THE CATH LAB TECH, "THERE WAS A DELAY IN THERAPY OF 3 TO 5 MINUTES." PUMP STRIPS OR X-RAY ARE NOT AVAILABLE. THE PUMP USED WAS THE IAP-0500. PER THE RISK MGR "THE PT WAS IN VERY BAD SHAPE COMING INTO THE LAB."

    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. MF0042502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death INTRA-AORTIC BALLOON PUMP