BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE 8 FR. 40CC IAB WITH GLI

    MDR report key: 703709 · Received April 20, 2006

    Report

    Report Number
    2248146-2006-00514
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Date of Event
    February 14, 2005
    Report Date
    April 20, 2006
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP BENT COMING OUT OF PACKAGE. ATTEMPT TO INSERT GUIDE WIRE THROUGH UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 40CC IAB WITH GLI INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0320 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR