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

Model Number CNS000004

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2018

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.

Event Description

Reporting a broken scalp electrode that was used for internal fhr monitoring during childbirth.The defective scalp electrode breaks when removing the scalp electrode.The tip of the scalp electrode remains under the skin of the baby's head.

Event Description

Reporting a broken scalp electrode that was used for internal fhr monitoring during child birth.The defective scalp electrode breaks when removing the scalp electrode.The tip of the scalp electrode remains under the skin of the baby's head.

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.Additional information received 04 dec 2018: child was born (b)(6) 2018 at 38+2 weeks.Baby was born without complication and discharged from the hospital.On (b)(6) 2018 the baby was taken to the hospital when the mother noticed a piece of electrode sticking out of scalp, the remaining piece was removed with pliers and the wound was cleaning without signs of infection.5 weeks later the baby was reported to have a fever and an "increase in infection rate".There was no mention of the prior incident with the broken electrode and the infection was described as inexplicable.The baby was treated with antibiotics.The device was discarded, the lot number is not known, and no pictures or detailed description of the scalp are available for any of the incidents mentioned above.Because the cause of the reported infection is not known, and no information was available, at this time we cannot confirm if the device contributed to the reported infection.No further information will be made available but clinical innovations will continue to monitor and trend all reported events associated with this device.

• Brand Name: GOLDTRACE FETAL SCALP ELECTRODE (FSE)
• Type of Device: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7782791
• MDR Text Key: 117137047
• Report Number: 1722684-2018-00011
• 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,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: CNS000004
• Device Lot Number: 180367
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 1 DA