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

Model Number	ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 20 FR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male, mentally handicapped and recent decreased appetite, urosepsis and metabolic encephalopathy.Procedure: gastro tube insertion.The retention balloon broke while inflating under fluoroscopy.Both pieces removed without known harm to patient.A new one placed without difficulty.Manufacturer response for tubes, gastrointestinal (and accessories), entuit thrive (per site reporter): will obtain.

• Brand Name: ENTUIT THRIVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES, INC.; 4700 s overland dr; tucson AZ 85714
• MDR Report Key: 17441704
• Report Number: 17441704
• Device Sequence Number: 2597900
• Product Code: KNT
• UDI-Device Identifier: 00827002356184
• UDI-Public: (01)00827002356184(17)251220(10)10971C001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/27/2023
• Report Date (Section F): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENTUITTM THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE - 20 FR
• Device Catalogue Number: 70-0041-220
• Device Lot Number: 10971C001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 07/27/2023