BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 8202869 · Received December 28, 2018

    Report

    Report Number
    1722684-2018-00020
    Event Type
    Injury
    Date Received
    December 28, 2018
    Report Date
    December 27, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS VERY IMPORTANT FOR THE FSE TO BE APPLIED CORRECTLY TO HAVE THE BEST RESULTS OF MONITORING AND REMOVAL AT THE END OF DELIVERY. IT IS IMPERATIVE THAT THE FSE NOT BE ROTATED MORE THAN 1 ½ TURN WHEN APPLYING IT TO THE BABY'S SCALP. IF THE ELECTRODE IS EXCESSIVELY TORQUED DURING (E.G. ROTATED > 1 ½ TURNS CLOCKWISE) APPLICATION TO THE PRESENTING PART OR IF THE ELECTRODE WAS ROTATED IN THE INCORRECT DIRECTION WHEN REMOVING FROM THE SCALP. THE INSTRUCTIONS FOR REMOVAL OF THE FSE IN THE IFU READS AS FOLLOWS: "REMOVE SPIRAL NEEDLE BY GRASPING ELECTRODE WIRES AS CLOSE TO FETAL PRESENTING PART AS POSSIBLE AND TWIST COUNTER-CLOCKWISE UNTIL FREE FROM PRESENTING PART". WHEN REMOVING THE FSE, IT IS VERY IMPORTANT TO MAKE SURE THAT THE CLINICIANS ARE TWISTING IT COUNTER-CLOCKWISE AS CLOSE TO THE PRESENTING PART, AS POSSIBLE. IF IT WAS INSERTED CORRECTLY, IT SHOULD NOT TAKE MORE THAN A 1 ½ TURN TO REMOVE IT. EDUCATION ON PROPER INSERTION AND REMOVAL ALONG WITH REVIEWING OF THE IFU'S ARE VERY IMPORTANT FOR ANY CLINICIAN USING THIS PRODUCT. THE DEVICE WAS DISCARDED, THE LOT NUMBER IS NOT KNOWN. NO FURTHER INFORMATION WILL BE MADE AVAILABLE BUT CLINICAL INNOVATIONS WILL CONTINUE TO MONITOR AND TREND ALL REPORTED EVENTS ASSOCIATED WITH THIS DEVICE. THIS EVENT IS BEING REPORTED RETROACTIVELY. THOUGH THE EVENT REPORTED DOES NOT MEET THE DEFINITION OF "SERIOUS" INJURY/ILLNESS, THE POSSIBILITY OF AN INFECTION IS NOT REMOTE. INFECTION ITSELF DOES NOT MEET THE DEFINITION OF "SERIOUS" INJURY/ILLNESS, BUT IT CAN, IN VERY REMOTE CASES, LEAD TO SEPSIS, WHICH COULD POTENTIALLY BE A LIFE-THREATENING ILLNESS. AT THIS TIME, CLINICAL INNOVATIONS HAS DECIDED TO REPORT ANY FSE-RELATED EVENT INDICATING INFECTION, SUSPECTED INFECTION, OR EVEN SWELLING AND REDNESS WHICH REQUIRED TREATMENT (I.E. ANTIBIOTICS, CLEANING, SUTURING, INCISION) AS "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)" IN THE UNITED STATES. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT, BUT CLINICAL INNOVATIONS CONTINUES TO MONITOR AND TREND ALL FSE RELATED EVENTS."

    Description of Event or Problem · 1

    THE FSE SPIRAL TIP BROKE DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041680 FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE HGP CLINICAL INNOVATIONS, LLC UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other