BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDTRACE

    MDR report key: 7106731 · Received December 11, 2017

    Report

    Report Number
    1722684-2017-00012
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 3, 2017
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE DEVICE WAS NOT RETURNED, THEREFORE THE DEVICE WAS NOT ABLE TO BE EXAMINED, AND THE LOT NUMBER WAS NOT CONFIRMED. IT WAS REPORTED THAT THE ELECTRODE WAS DIFFICULT TO PLACE AND THAT THERE WERE 3 CASES OF INFANT'S GETTING INFECTIONS AT THE REMOVAL SITE. IT WAS NOT REPORTED WHETHER THE ELECTRODE WAS REMOVED AS STATED IN THE IFU. THE INSTRUCTIONS FOR REMOVAL 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". 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. BASED ON THE INFORMATION REPORTED, I FEEL THAT THE CLINICIANS ARE NOT REMOVING THE DEVICE CORRECTLY WHICH COULD BE CAUSING A MORE DIFFICULT REMOVAL AND INFECTIONS. MORE EDUCATION ON PROPER INSERTION AND REMOVAL ALONG WITH REVIEWING OF THE IFU'S ARE INDICATED.

    Additional Manufacturer Narrative · 1

    THE GOLDTRACE WAS TESTED FOR BIOCOMPATIBILITY AND PASSED ALL TEST. WE ARE INVESTIGATING THE COMPLAINT AND GATHERING MORE INFORMATION TO DETERMINE WHAT COULD HAVE CAUSED THE INFECTION ON THE PATIENT.

    Description of Event or Problem · 1

    HOSPITAL NARRATIVE: "THIS IS TO INFORM YOU THAT OUR DELIVERY UNIT HAS INFORMED VALVIRA, THE (B)(6) NATIONAL REGISTERY THAT WE HAVE FACED PROBLEMS WITH GOLDTRACE IU-SCALP. THE INSERTION SITE OF THE SCALP WAS INFECTED IN 3 CHILDREN, FROM WHOM 2 RECEIVED IV-ANTIBIOTICS AND ONE WAS TREATED WITH LOCAL ANTIBIOTICS. IN OUR INFORMATION TO VALVIRA WE HAVE ALSO DESCRIBED THAT THE MIDWIVES AND DOCTORS HAVE EXPERIENCED MORE CHALLENGES TO PLACE THE SCALP ELECTRODE THAN WITH OUR PREVIOUS ELECTRODES."

    Description of Event or Problem · 1

    HOSPITAL NARRATIVE: "THIS IS TO INFORM YOU THAT OUR DELIVERY UNIT HAS INFORMED THE (B)(6) NATIONAL REGISTERY THAT WE HAVE FACED PROBLEMS WITH GOLDTRACE IU-SCALP. THE INSERTION SITE OF THE SCALP WAS INFECTED IN 3 CHILDREN, FROM WHOM 2 RECEIVED IV-ANTIBIOTICS AND ONE WAS TREATED WITH LOCAL ANTIBIOTICS. IN OUR INFORMATION TO (B)(6) WE HAVE ALSO DESCRIBED THAT THE MIDWIVES AND DOCTORS HAVE EXPERIENCED MORE CHALLENGES TO PLACE THE SCALP ELECTRODE THAN WITH OUR PREVIOUS ELECTRODES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885887 GOLDTRACE FETAL SPIRAL ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS000004 170459

    Patients

    Seq Age Sex Outcome Treatment
    1 1 WK Hospitalization