BEUDAMED
    FDA Adverse Event Death Summary report: N

    8 FR. CO-LUMEN 40 CC. IAB

    MDR report key: 288654 · Received August 1, 2000

    Report

    Report Number
    2248146-2000-00011
    Event Type
    Death
    Date Received
    August 1, 2000
    Date of Event
    June 9, 2000
    Report Date
    June 13, 2000
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER IABP FOR 40 HOURS, THE 8FR. IAB RUPTURED. ON 07/24/2000, THE FOLLOWING INFO WAS REPORTED: THE IAB WAS INSERTED INTO THE PT IN 2000. TWO DAYS LATER AFTER IABP FOR 40 HOURS, THE IAB LEAKED AND THE IAB WAS REMOVED. THE PT WENT ON TO EXPIRE A FEW HOURS LATER. EVENT COMPLICATIONS: UNKNOWN - REPORTED 06/13/2000 - THE PT EXPIRED - REPORTED 07/24/2000. PT'S CURRENT STATUS: EXPIRED - REPORTED 07/24/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 FR. CO-LUMEN 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0884-00-0009 3/2/02

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death