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

Model Number CNS000004

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 07/21/2017

Event Type  Injury  

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

On the (b)(6) 2017, a caput electrode was placed during the delivery for fetal monitoring of the baby.However, during the removal of the electrode, a piece of metal of this electrode remained stuck under the skin of the baby's head.This has been proven 20 days afterwards through a radiological examination, because of a painful swelling on the head.The broken part has been surgically removed afterwards.Initially another supplier was notified in this case.After investigation, it appeared however that a scalp electrode of bma (scalp electrode goldtrace) is concerned.The complaint relates to the scalp electrode with reference number cns000004.Because this incident was only diagnosed later on, it is not clear which lot number exactly is concerned.The lot numbers being in the hospital at the time of the signaling are 170714 and 170341.

Manufacturer Narrative

No additional information could be obtained for this report.The product was discarded and further assessment could not be conducted not conducted.

Event Description

On the 21st of july 2017, a caput electrode was placed during the delivery for fetal monitoring of the baby.However, during the removal of the electrode, a piece of metal of this electrode remained stuck under the skin of the baby's head.This has been proven 20 days afterwards through a radiological examination, because of a painful swelling on the head.The broken part has been surgically removed afterwards.Initially another supplier was notified in this case.After investigation, it appeared however that a scalp electrode of bma (scalp electrode goldtrace) is concerned.The complaint relates to the scalp electrode with reference number: (b)(4).Because this incident was only diagnosed later on, it is not clear which lot number exactly is concerned.The lot numbers being in the hospital at the time of the signaling are 170714 and 170341.

• Brand Name: GOLDTRACE FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SCALP ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7106754
• MDR Text Key: 94479796
• Report Number: 1722684-2017-00006
• Device Sequence Number: 1
• Product Code: HGP
• 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,foreign,user faci
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/10/2018

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 Expiration Date: 06/11/2019
• Device Model Number: CNS000004
• Device Lot Number: 170714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 DA