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

Model Number CNS000004/

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2018

Event Type  Injury  

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.The device was discarded, the lot number is not known.No further information will be made available but clinical innovations will continue to monitor and trend all reported events associated with this device.

Event Description

A piece of scalp electrode has been removed from the head of a child (pp+7).This has been done by the pediatric surgeon.Normally this should have come out completely when loosening.

• 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: andrea gadsby ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 8191385
• MDR Text Key: 131221924
• Report Number: 1722684-2018-00018
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 00814247020505
• UDI-Public: 00814247020505
• Combination Product (y/n): N
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/21/2018

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
• Device Operator: Health Professional
• Device Model Number: CNS000004/
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 DA