BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 3954549 · Received July 17, 2014

    Report

    Report Number
    2248146-2014-00262
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    January 29, 2010
    Report Date
    February 5, 2010
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ABLE TO PASS THE LABORATORY 0.025" GUIDEWIRE THROUGH THE IAB LUMEN WITHOUT DIFFICULTY. THERE WERE NO KINKS OR BLOCKAGE FOUND. THE REPORTED PROBLEM COULD NOT BE CONFIRMED BY THE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. INTERNAL FILE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE GUIDE WIRE COULD NOT BE INSERTED INTO THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420223 LINEAR 7.5 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0475 2255

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death