BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE

    MDR report key: 1840215 · Received September 14, 2010

    Report

    Report Number
    MW5017477
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 14, 2010
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC BALLOON CATHETER INSERTED, ENGAGED, BUT AFTER 4 MINUTES OF CYCLING, THE ALARM SOUNDED INDICATING A LEAK IN THE SYSTEM. THE BALLOON WAS REMOVED AND BLOOD HAD LEAKED INSIDE THE BALLOON. THIS OCCURRED ON TWO DIFFERENT BALLOON CATHETERS. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: HEMODYNAMIC INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE INTRA AORTIC BALLOON CATHETER DSP DATASCOPE FIDELITY 8 FR. 40 23470437
    2 DATASCOPE FIDELITY CATHETER 8 FR. DSP DATASCOPE 22932084

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening