FDA Adverse Event Malfunction Summary report: N

GOLDTRACE

MDR report key: 7106710 · Received December 11, 2017

Report

Report Number: 1722684-2017-00008
Event Type: Malfunction
Date Received: December 11, 2017
Report Date: November 22, 2017
Manufacturer: CLINICAL INNOVATIONS, LLC
Product Code: HGP
PMA / PMN Number: K030691
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
885183	GOLDTRACE	FETAL SPIRAL ELECTRODE	HGP	CLINICAL INNOVATIONS, LLC	CNS000004	UKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization