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

Model Number	CNS000004
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned yet, therefore the device has not been examined.The device was either lot number 171421 or 170934.Since the spiral was reported that it broke during insertion, 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, i feel 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.
Event or Problem Description
On the (b)(6) 2018 a midwife applied a scalp electrode during delivery (fully dilated).The electrode immediately broke off at the first movement of application.Fortunately she immediately noticed this and reported the incident to the pediatrician.The pediatrician made an x-ray of the skull of the baby on the (b)(6) 2018.It indeed appeared that the electrode wire was still under the skin.You cannot feel it on the baby's head, but it will be removed in consultation with the doctor and the plastic surgeon.

• Brand Name: GOLDTRACE 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: 7287240
• Report Number: 1722684-2018-00002
• Device Sequence Number: 13756100
• 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: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: Other Health Care Professional
• Device Model Number: CNS000004
• Device Lot Number: UKNOWN
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 02/21/2018
• 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: Required Intervention
• Patient Age: 1 HR