BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 50CC IAB

    MDR report key: 3946235 · Received July 2, 2014

    Report

    Report Number
    2248146-2014-00124
    Event Type
    Death
    Date Received
    July 2, 2014
    Report Date
    October 4, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) AT 1:30 PM A SENSATION PLUS 50 CC BALLOON WAS INSERTED AS PART OF OUR CONTROLLER MARKET RELEASE. THE PT WAS TAKEN TO THE CATH LAB EMERGENCY DUE TO RAPID DETERIORATION AND WENT INTO CARDIAC ARREST WHEN ENTERING THE CATH LAB. THE SENSATION PLUS 50 CC BALLOON WAS PLACED BY THE DOCTOR WITHOUT DIFFICULTY. THE PT WAS CODED FOR 30 MINUTES WITH THE IAB ASSISTING THE PT, AND THEN THE PT EXPIRED. THE DEATH WAS NOT ATTRIBUTED TO THE SENSATION PLUS BALLOON. THE BALLOON WAS REMOVED POST-MORTEM AND WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385532 SENSATION 50CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP., 0684-00-9991

    Patients

    Seq Age Sex Outcome Treatment
    1 Death