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U.S. Department of Health and Human Services

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

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CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SPIRAL ELECTRODE Back to Search Results
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 infomration 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 straighten 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. Vi 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). The bag of the goldtrace wa 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.

 
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Brand NameGOLDTRACE
Type of DeviceFETAL 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 Key7106735
MDR Text Key94808079
Report Number1722684-2017-00009
Device Sequence Number1
Product Code HGP
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 11/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCNS000004
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/11/2017 Patient Sequence Number: 1
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