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

Model Number	CNS000004
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 7287243
• Report Number: 1722684-2018-00004
• Device Sequence Number: 11056956
• 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
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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 Expiration Date: 02/22/2020
• Device Model Number: CNS000004
• Device Lot Number: 171214
• Was Device Available for Evaluation?: No
• 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: Hospitalization; Required Intervention
• Patient Age: 1 HR