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

Model Number CNS000004

Device Problem Human Factors Issue (2948)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

This has an extremely rare occurrence and this type of failure is caused by use error of the product either when placing the device (over-rotation) and/or upon removing the device (under-rotation).Clinical innovations is trying to get more information regarding the incident.

Event Description

After the phone conversation with your technical department, i hereby send you one out of three fetal scalp electrodes of the brand goldtrace, that have been straightened out or fastened during the removal of the scalp electrode in the post-partum phase.Surgery procedure was proceeding accordingly to remove the fetal scalp electrode because of the difficulty of removing it from the child's head.We do not expect to have this kind of problems with the goldtrace, which is the reason why it is difficult to provide a lot number.I have all the goldtraces in a box with mixed lot numbers, and these are: 170134, 170347, 161433, 161317.The child that had surgery to remove the fetal scalp from its head was born (b)(6) 1504.The bag of the goldtrace was threw away of course.This incident was reported as a deviation.The pediatrician will follow up this case with the child continuously.Will dispatched the fetal scalp electrode which was removed by surgery (b)(6) 2017.

• Brand Name: GOLDTRACE
• Type of Device: FETAL SPIRAL 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: 7106710
• MDR Text Key: 95764333
• Report Number: 1722684-2017-00008
• Device Sequence Number: 1
• Product Code: HGP
• 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,foreign
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CNS000004
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization