BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOS CATHETER

    MDR report key: 6916072 · Received October 5, 2017

    Report

    Report Number
    MW5072610
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BTG
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN IR PULMONARY ARTERIOGRAM BILATERAL, THE EKOS INTRAVASCULAR ULTRASOUND DECLOTTING MACHINE GAVE AN ERROR STATING, "THE CONTROL UNIT HAS TURNED OFF ULTRASOUND OUTPUT BECAUSE IT HAS DETECTED AN EXCESSIVE INSTANTANEOUS AVERAGE POWER OUTPUT" PER ICU RN'S. ADDITIONALLY, PHYSICIAN NOTES IN PROCEDURE DICTATION THAT A RELIABLE LEFT PULMONARY ARTERY PRESSURE COULD NOT BE OBTAINED VIA THE EKOS CATHETER. THERE WAS NO HARM TO THE PATIENT, AND THE PATIENT RECEIVED THE FULL DOSE OF TPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695413 EKOS CATHETER EKOS CATHETER KRA BTG 500-55106 170501009-006(R)
    695414 EKOS CATHETER EKOS CATHETER KRA BTG 500-55106 170612061-004(L)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization