BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1938691 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00915
    Event Type
    Death
    Date Received
    December 21, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR# 1219856-2010-00914 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT IN THE CARDIOLOGY DEPARTMENT, A FEMALE PT WITH THE DIAGNOSIS OF CARDIOGENIC SHOCK AND LEFT MAIN STENOSIS HAD CORONARY ANGIOPLASTY AND STENTING. THE PATIENT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) PLACED VIA THE LEFT FEMORAL ARTERY. THE IAB BECAME STUCK WHEN THE MD WAS ADVANCING IT THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH. THE IAB WAS REMOVED AND THERE WAS A THIRD ATTEMPT WITH A PLASTIC 8FR WHICH ALLOWED THE IAB TO PASS WITHOUT PROBLEM. THERE WAS A 20 MINUTE DELAY NOTED. THE PT EXPIRED 7 DAYS LATER.

    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. MF0021654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death GPIIB/ILLA| HEPARIN| CLOPIDOGREL