BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1070049 · Received July 3, 2008

    Report

    Report Number
    1219856-2008-00316
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 3, 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 BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON (IAB) STARTED UNRAVELING DURING INSERTION. AS A RESULT, THE IAB WAS REMOVED AND REPLACED WITH ANOTHER 30CC IAB. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    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. MF7118002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK