BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 1230362 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00523
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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) WAS INSERTED VIA THE LEFT GROIN WHILE THE PATIENT WAS IN THE CATH LAB. THE MD FOUND THAT THE CATHETER COULD NOT BE FLUSHED AND AS A RESULT, THE IAB WAS REMOVED. A REQUEST WAS MADE FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF8061336

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK