MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC GOLD TRACE FETAL SCALP ELECTRODE

Model Number	CNS000004
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812); Staphylococcus Aureus (2058); Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Information from the parents: a scalp electrode was applied on the scalp of my child.Because of bradycardia during contractions.Need to monitoring risk of fetal hypoxia.The (b)(6) 2018 (d12), a sudden tumefaction of 2cm appeared on the occipital part with, at the summit, a small crust corresponding to the electrode positioning.The (b)(6) 2018 (d16), the tumefaction is bigger (2,5 cm) with a purulent flow.Diagnosis: under skin abscess with staphylococcus inoculated by scalp electrode monitoring per partum.Broken fetal scalp electrode under the skin caused tumefaction with a purulent flow.

• Brand Name: GOLD TRACE FETAL SCALP ELECTRODE
• Common Device Name: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7781977
• Report Number: 1722684-2018-00010
• Device Sequence Number: 11278050
• Product Code: HGP
• UDI-Device Identifier: 00814247020505
• UDI-Public: 00814247020505
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K030691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CNS000004
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 1 DA