BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1592940 · Received January 29, 2010

    Report

    Report Number
    1219856-2010-00052
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 29, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CATH LAB THAT THE INTRA-AORTIC BALLOON ('IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SUPER ARROW-FLEX ('SAF') SHEATH INTO THE PT'S FEMORAL ARTERY. AS THE IAB WAS BEING INSERTED INTO THE SAF SHEATH, THE IAB BECAME TIGHT AND AS A RESULT, THE IAB WAS PULLED OUT OF THE SAF SHEATH. THE SAF SHEATH WAS REMOVED. THE MD USED ANOTHER INSERTION TRAY'S SAF SHEATH AND THE SAME IAB WAS INSERTED WITHOUT DIFFICULTY. THE IAB THERAPY COMMENCED WITHOUT EVENT. THERE WERE NO REPORTED PT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED BY THE SALES REPRESENTATIVE ON 1/22/2010, STATED, THE MD USED THE SAME INSERTION SITE.

    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. MF9120749

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK