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

Model Number CNS000004

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 02/11/2018

Event Type  malfunction  

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 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
• Type of Device: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: santosh bhagat ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 7287243
• MDR Text Key: 100901853
• Report Number: 1722684-2018-00004
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 00814247020505
• UDI-Public: 00814247020505
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: CNS000004
• Device Lot Number: 171214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 1 HR