BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER 8FR 40CC

    MDR report key: 1160915 · Received September 12, 2008

    Report

    Report Number
    MW5008296
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 12, 2008
    Manufacturer
    DATASCOPE, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC BALLOON RUPTURE LEAKING BLOOD BACK INTO CATHETER. DIAGNOSIS OR REASON FOR USE: POST-OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER 8FR 40CC NONE DSP DATASCOPE, INC. CS 100 20610162

    Patients

    Seq Age Sex Outcome Treatment
    1