BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1203411 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00484
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) PREMATURELY UNWRAPPED PRIOR TO INSERTION. AS A RESULT, THE IAB WAS NOT USED. NEW INFORMATION RECEIVED STATED THAT THE IAB WAS INSERTED INTO THE SHEATH WHICH WAS IN THE PATIENT. THE IAB BEGAN TO UNWRAP WHILE THE MD WAS ADVANCING IT INTO THE SHEATH.

    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. MF8072073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK