BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1170213 · Received September 11, 2008

    Report

    Report Number
    1219856-2008-00430
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    September 11, 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 BY THE CLINICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A MALE PATIENT WITH A FEMORAL APPROACH. THE INTRA-AORTIC BALLOON (IAB) WAS PLACED IN THE AORTA WITH SOME DIFFICULTY. WHEN THEY TRIED TO INFLATE THE IAB, THE HIGH PRESSURE ALARM RANG. THEY TRIED TO INFLATE THE IAB MANUALLY, BUT THE HIGH PRESSURE ALARM STILL RANG. AS A RESULT, THE SHEATH AND CATHETER WERE EXCHANGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF7076256

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK