MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES, INC. ENTUIT THRIVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 18 FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The interventional radiology department has placed three entuit thrive balloon retention gastrostomy tubes in the last 6 months that have become dislodged or fallen out because something was attached to the balloon port, which is not labeled, causing the balloon to deflate.The balloon is a retention balloon to keep the tube in the stomach.One dislodged tube resulted in a patient having to have a surgical procedure; the other 2 had to have the tubes replaced.This port is not labeled as a balloon, while the other 2 ports are labeled as medicine port and feeding port.The patient involved in this event required replacement of their g-tube.

• Brand Name: ENTUIT THRIVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES, INC.; 4700 s overland drive; tucson AZ 85714
• MDR Report Key: 7468187
• Report Number: 7468187
• Device Sequence Number: 172575
• Product Code: KNT
• UDI-Device Identifier: 00827002356177
• UDI-Public: (01)00827002356177(17)191218(10)971702
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018
• Report Date (Section F): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 12/18/2019
• Device Model Number: ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 18 FR
• Device Catalogue Number: 70-0041-118
• Device Lot Number: 971702
• Other Device ID Number: G35617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO OTHER THERAPIES.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Date Report Sent to FDA: 04/23/2018