BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 1052550 · Received May 22, 2008

    Report

    Report Number
    1219856-2008-00241
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K040801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. AFTER THE IAB WAS INSERTED, THE CARDIOLOGIST "KEPT PULLING AIR OUT OF THE LUMEN OF THE BALLOON." "THERE WAS NO BLOOD WHEN HE DREW BACK." AS A RESULT, THE MD INSERTED ANOTHER IAB WITHOUT DIFFICULTIES. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention