BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR 30 CC

    MDR report key: 1002585 · Received February 8, 2008

    Report

    Report Number
    1219856-2008-00027
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K040801
    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 WHILE IN THE CATH LAB, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) WITHOUT INCIDENT. A "LEAKAGE" WAS NOTED AT THE STOPCOCK CONNECTION OF THE EXTENSION TUBE. AS A RESULT, THE EXTENSION TUBE WAS EXCHANGED. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF7097189

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK