BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 375465 · Received February 5, 2002

    Report

    Report Number
    2248146-2002-00002
    Event Type
    Death
    Date Received
    February 5, 2002
    Date of Event
    September 14, 2001
    Report Date
    January 4, 2002
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PATIENT IN 2000 AT 2:45 A.M. THE IAB DID NOT MALFUNCTION. THE PATIENT HAD AN AORTIC DISSECTION AND WENT ON TO EXPIRE FROM THIS EVENT. NO IAB WAS RETURNED TO DATASCOPE FOR EVALUATION. EVENT COMPLICATIONS: AORTIC DISSECTION/DEATH-REPORTED 2002. PATIENT'S CURRENT STATUS: EXPIRED-RPT'D 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death