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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 Difficult to Insert (1316)
Patient Problem Unspecified Infection (1930)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Unfortunately, the device was not returned, therefore the device was not able to be examined, and the lot number was not confirmed. It was reported that the electrode was difficult to place and that there were 3 cases of infant's getting infections at the removal site. It was not reported whether the electrode was removed as stated in the ifu. The instructions for removal 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". 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. Based on the information reported, i feel that the clinicians are not removing the device correctly which could be causing a more difficult removal and infections. More education on proper insertion and removal along with reviewing of the ifu's are indicated.
 
Event Description
Hospital narrative: "this is to inform you that our delivery unit has informed valvira, the (b)(6) national registery that we have faced problems with goldtrace iu-scalp. The insertion site of the scalp was infected in 3 children, from whom 2 received iv-antibiotics and one was treated with local antibiotics. In our information to valvira we have also described that the midwives and doctors have experienced more challenges to place the scalp electrode than with our previous electrodes. ".
 
Manufacturer Narrative
The goldtrace was tested for biocompatibility and passed all test. We are investigating the complaint and gathering more information to determine what could have caused the infection on the patient.
 
Event Description
Hospital narrative: "this is to inform you that our delivery unit has informed the (b)(6) national registery that we have faced problems with goldtrace iu-scalp. The insertion site of the scalp was infected in 3 children, from whom 2 received iv-antibiotics and one was treated with local antibiotics. In our information to (b)(6) we have also described that the midwives and doctors have experienced more challenges to place the scalp electrode than with our previous electrodes. ".
 
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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 Key7106731
MDR Text Key278154619
Report Number1722684-2017-00012
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K030691
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,Followup
Report Date 12/03/2017
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
Device Model NumberCNS000004
Device Lot Number170459
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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