FDA Adverse Event Injury Summary report: N

G-JET

MDR report key: 4934565 · Received July 21, 2015

Report

Report Number: 4934565
Event Type: Injury
Date Received: July 21, 2015
Date of Event: April 21, 2015
Report Date: July 21, 2015
Manufacturer: APPLIED MEDICAL TECHNOLOGY INC.
Product Code: KNT
Adverse Event: Yes
Report Source: User Facility report
Reporter Location: NC, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT IS A BABY WITH MULTIPLE MEDICAL PROBLEMS, INCLUDING FAILURE TO THRIVE, GERD, AND PROBLEMS WITH EMESIS AND RETCHING. HAD GAINED SOME WEIGHT WITH NG TUBE FEEDS. HIS PARENTS REQUESTED A G-TUBE THAT WAS PLACED ABOUT FOUR MONTHS AGO. HE DID NOT TOLERATE GASTRIC TUBES FEEDS, AND A GASTROJEJUNOSTOMY CHANGE WAS PERFORMED ABOUT THREE MONTHS AGO. THE TUBE EXCHANGE WAS PERFORMED BY AN INTERVENTIONAL RADIOLOGIST WITH FLUOROSCOPY GUIDANCE. THE PROCEDURE NOTE READS, "DUE TO THE PATIENT'S SIZE, A 14 FRENCH, 1.7 CM AMT CATHETER WAS CUT TO 25 CM (ORIGINALLY 30 CM). THE GLIDEWIRE WAS EXCHANGED FOR A BENTSON WIRE AND THE KUMPE CATHETER WAS THEN EXCHANGED FOR THE NEW G-J TUBE OVER THE WIRE. THE WIRE WAS REMOVED AND CONTRAST WAS INJECTED UNDER FLUOROSCOPY TO DOCUMENT POSITION OF THE TIP IN THE JEJUNUM AND THE GASTROSTOMY PORT IN THE STOMACH. THE RETENTION BALLOON WAS THEN INFLATED WITH DILUTE CONTRAST." HE WAS SEEN IN CLINIC ABOUT TWO MONTHS AGO WHERE A BARIUM SWALLOW WAS DONE, AND IT WAS NOTED THAT THE G-J TUBE COURSED FROM THE STOMACH INTO THE DUODENUM BUT THEN LEFT THE SMALL INTESTINE AND THE TIP ENDED UP IN THE STOMACH. THE CHILD WAS ADMITTED AND TAKEN FOR SURGERY TO REPAIR THE PERFORATION AND REPLACE THE TUBE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
470819	G-JET	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	APPLIED MEDICAL TECHNOLOGY INC.	GJ-1417-30	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	8 MO		Hospitalization\| R