BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTRA AORTIC BALLOON CATHETER 40CC/8FR.

    MDR report key: 2781917 · Received October 4, 2012

    Report

    Report Number
    MW5027194
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 4, 2012
    Manufacturer
    TELEFLEX, INC
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC CATHETER INSERTED IN RIGHT FEMORAL ARTERY. BALLOON PUMPING STARTED W/O INCIDENT. APPROX 45 MINS LATER, THE HIGH PRESSURE / BALLOON LEAK ALARM APPEARED ON THE CONSOLE. UPON INVESTIGATION, THE BALLOON WAVEFORM WAS INDICATIVE OF A BALLOON LEAK. THERE WAS NO BLOOD IN THE CATHETER LUMEN SO A LEAK EXTERNAL TO THE PT WAS SUSPECTED. THE SURGEON WAS NOTIFIED. THE CATHETER REPLACED W/O INCIDENT. NO HARM WAS DONE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTRA AORTIC BALLOON CATHETER 40CC/8FR. INTRA AORTIC BALLOON CATHETER DSP TELEFLEX, INC GG 10075

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other