BEUDAMED
    FDA Adverse Event Summary report: N

    FIDELITY 8 FR. 40CC IAB

    MDR report key: 1023703 · Received April 1, 2008

    Report

    Report Number
    2248146-2008-00532
    Date Received
    April 1, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (4) 2008, THE "LEAK" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE CATHETER TUBING. THE DOCTOR TRIED TO REMOVE THE IAB, BUT IT WAS STUCK INSIDE THE PT'S ILIAC ARTERY AND THERE WAS INJURY TO ARTERY. PT EXPIRED ON (B) (4), 2008. DATASCOPE WAS NOTIFIED, IT WAS UNK IF THE PT'S DEATH WAS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELITY 8 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0329 1893

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention