BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDTRACE FETAL SCALP ELECTRODE

    MDR report key: 7287243 · Received February 21, 2018

    Report

    Report Number
    1722684-2018-00004
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    February 11, 2018
    Report Date
    February 21, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    UDI-DI
    00814247020505
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPIRAL WAS REPORTED TO BREAK DURING REMOVAL, IT COULD HAVE BEEN FROM BEING EXCESSIVELY TORQUED. IF THE ELECTRODE IS EXCESSIVELY TORQUED DURING (E.G. ROTATED > 1 ½ TURNS CLOCKWISE) APPLICATION TO THE PRESENTING PART, THEN THIS COULD HAVE CAUSED THE NEEDLE TO BREAK AND REMAIN EMBEDDED IN THE PATIENT'S SCALP. BASED ON THE INFORMATION REPORTED, WE BELIEVE THAT USING EXCESSIVE TORQUE WHEN APPLYING THE ELECTRODE TO THE BABY'S HEAD IS THE CAUSE OF THE BREAKAGE OF THE SPIRAL NEEDLE TIP. MORE EDUCATION ON PROPER INSERTION ALONG WITH REVIEWING OF THE IFU'S ARE INDICATED. UNFORTUNATELY, THE DEVICE WAS THROWN AWAY AFTER USE AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    HAD A CALL FROM (B)(6) REPORTING AN INCIDENT LAST NIGHT WHERE A GOLDTRACE SCALP ELECTRODE GOT STUCK AND HAD TO BE REMOVED SURGICALLY FROM THE BABY'S HEAD. UNFORTUNATELY THE ELECTRODE (LOT NUMBER 171214) HAS BEEN THROWN AWAY. WE ARE AWAITING MORE DETAILED INFORMATION FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131193 GOLDTRACE FETAL SCALP ELECTRODE FETAL SCALP ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS000004 171214 00814247020505

    Patients

    Seq Age Sex Outcome Treatment
    1 1 HR Hospitalization| R