BEUDAMED
    FDA Adverse Event Death Summary report: N

    8 FR. CO-LUMEN 40 CC. IAB

    MDR report key: 334846 · Received May 25, 2001

    Report

    Report Number
    2248146-2001-00016
    Event Type
    Death
    Date Received
    May 25, 2001
    Date of Event
    February 22, 2001
    Report Date
    April 26, 2001
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 8 FR. IAB WAS INSERTED INTO THE PATIENT IN 2001 AT 3:30 A.M. TWO DAYS LATER AT 4:00 A.M., THE IAB LEAKED. DIFFICULTY WAS ENCOUNTERED REMOVING THE IAB AND THE IAB NEEDED TO BE SURGICALLY REMOVED. IT WAS REPORTED THAT THE IAB FAILED DUE TO MULTIPLE PLAQUES IN THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24571 8 FR. CO-LUMEN 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0884-00-0009 11/17/02

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death