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

Model Number CNS00004

Device Problem Human Factors Issue (2948)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2017

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 infomration regarding the incident.

Event Description

Hospital narrative translated to english: "in the last two weeks we had complications with the scalp electrode: -1x winding left with infection - 1x laceration of the skin after removing.In general we all have the impression that the scalp electrodes are very difficult to detach.It is for example after a caesarean section often not possible to remove the electrode by pulling apart the threads.The nurses also have the feeling that the spiral is longer than before.The lot number of these electrodes is 170347.We would like to receive your reaction to this.Can you also let us know if it is correct that the spiral is now longer than in the past? do you have an instruction to remove correctly the scalp electrode? maybe the customer can learn from that for the future".

Manufacturer Narrative

Clinical innovations was unable to obtain additional information regarding this incident to further evaluate the cause.

Event Description

Hopsital narrative translated to english: "in the last two weeks we had complications with the scalp electrode : - 1x windings left with infection - 1x laceration of the skin after removing.In general we all have the impression that the scalp electrodes are very difficult to detach.It is for example after a caesarean section often not possible to remove the electrode by pulling apart the threads.The nurses also have the feeling that the spiral is longer than before.The lot number of these electrodes is 170347.We would like to receive your reaction to this.Can you also let us know if it is correct that the spiral is now longer than in the past? do you have an instruction to remove correctly the scalp electrode? maybe the customer can learn from that for the future.".

• Brand Name: GOLDTRACE FETAL SCALP ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7106760
• MDR Text Key: 94817057
• Report Number: 1722684-2017-00011
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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: Health Professional
• Device Expiration Date: 06/09/2019
• Device Model Number: CNS00004
• Device Lot Number: 170347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization