BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 2245351 · Received September 8, 2011

    Report

    Report Number
    1219856-2011-00318
    Event Type
    Death
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2011-00317 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT, > (B)(6). ACCORDING TO THE EVENT THE PT WAS VERY SICK. WHILE IN THE CATH LAB AND AS THE PT WAS UNSTABLE AND CODING, THE SECOND SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED VIA THE PT'S FEMORAL ARTERY. AS THE MD WAS INSERTING THE INTRA-AORTIC BALLOON (IAB) INTO THE SAF SHEATH, THE IAB WOULD NOT PASS ALL THE WAY THROUGH THE SAF SHEATH. THE PROXIMAL END OF THE IAB MEMBRANE WOULD NOT EXIT THE DISTAL TIP OF THE SAF SHEATH. THE IAB AND SAF SHEATH WERE REMOVED. AN (B)(4)-LWS WAS PREPPED AND INSERTED THROUGH "IT'S OWN SHEATH" INTO THE SAME INSERTION SITE SUCCESSFULLY. THE FIRST AND SECOND EXCHANGE WAS COMPLETED SUCCESSFULLY UTILIZING A .018 SWG FROM THE CATH LAB STOCK. THE PT EXPIRED IN THE CATH LAB. IT IS UNK IF THE DELAY IN IABP TREATMENT CONTRIBUTED TO THE DEATH OF THE PT. THE PT WAS CODING SIMULTANEOUSLY TO THE ATTEMPTED IAB INSERTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF0042784

    Patients

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