BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR. 40CC IAB

    MDR report key: 1760458 · Received July 14, 2010

    Report

    Report Number
    2248146-2010-00353
    Event Type
    Death
    Date Received
    July 14, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 17, 2010
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: IT WAS VERY DIFFICULT TO INSERT THE BALLOON CATHETER OVER THE SHEATH. THEN, THE ERROR MESSAGE "PRESSURE" AND "VERIFY" SOUNDED. THE FACILITY IS ATTRIBUTING THE PT DEATH TO THE EVENT AND REPORTED 'WE LOST FURTHER 45 MINUTES, UNTIL THE NEW IABP BALLOON HAS BEEN INSERTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION 7FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0434 2380

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death