BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERWAND ED

    MDR report key: 9165896 · Received October 8, 2019

    Report

    Report Number
    9165896
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 17, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POWERWAND WAS SELECTED TO BE PLACED IN A CHILD. PATIENT'S PRIMARY RN ABLE TO ACCESS RIGHT AWAY IN LEFT UPPER EXTREMITY VEIN. A GOOD BLOOD FLASH OBTAINED AND THE GUIDE WIRE DEPLOYED. GUIDE WIRE ADVANCED EASILY, BUT WHEN RN TRIED TO ADVANCE THE CATHETER IT WOULD ONLY GO A LITTLE BIT. RN TRIED TO PULL OUT THE GUIDE WIRE TO RESET, BUT IT WOULD NOT COME OUT. RN DECIDED TO PULL BOTH THE CATHETER AND GUIDE WIRE OUT. RN NOTICED THAT THE CATHETER TIP AND THE GUIDE WIRE WAS BENT. THERE WAS NO HARM TO THE PATIENT. RN HAD PREVIOUS EXPERIENCE WITH PLACEMENT OF POWERWANDS WITH OTHER PATIENTS AND THIS IS THE FIRST TIME THAT SHE HAS EXPERIENCED THIS TYPE OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961253 POWERWAND ED INTRODUCER, CATHETER DYB ACCESS SCIENTIFIC, LLC M1621

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA