BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 2201454 · Received August 3, 2011

    Report

    Report Number
    1219856-2011-00285
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING PLACED INTO THE PATIENT'S FEMORAL ARTERY. AFTER THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED, THERE WAS AN ABSENCE OF THE PRESSURE SIGNAL ON THE MONITOR. AS A RESULT, ANOTHER BALLOON WAS SUCCESSFULLY PLACED USING A BIGGER INTRODUCER IN ORDER TO PROVIDE HEMOSTASIS. THERE WAS NO SERIOUS CONSEQUENCE TO THE PATIENT. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PATIENT. THERE WAS NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF1049957

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK