MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE; GASTROSTOMY TUBE

Model Number	70-0041-118
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Feeding Problem (1850)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is filed in connection with three user medwatch reports received by xeridiem on or about may 2, 2018.Information reported in these fields are as reported in the one user report on which a device was returned.The following three user medwatch reports were received by xeridiem: (b)(4).All three reports involved the same issue, the same device part number and the same device lot number.The user reports indicated event date within (b)(6) but this date precedes the manufacturing date for the lot code provided.Model number is xeridiem's part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, (b)(4).The device on user medwatch (b)(4) was returned for evaluation (devices on the other two reports were not returned).It was confirmed that incorrect connection was used in the inflation valve port.Device description in the ifu states the following: "the device contains one volve that allows for inflation and deflation of the silicone balloon." device funnel is printed "feed only" and "enteral meds only" to further clarify that this device is intended for enteral applications and the use of each port.If the initial check/device preparation is performed prior to any procedure as the ifu states, there should be no confusion of the device functionality and port usage.No procedure should be performed without following the ifu for correct placement and usage of the catheter.Codes chosen for patient code, device code, methods, results, and conclusions are selected with these comments in mind.
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.The dislodged tube resulted in a patient having to have a surgical procedure; the other 2 had to have the tubes replaced.The 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 surgical intervention.

• Brand Name: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 7563503
• Report Number: 2025851-2018-00013
• Device Sequence Number: 19162077
• 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
• PMA/510(K) Number: K130611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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 Expiration Date: 12/18/2019
• Device Model Number: 70-0041-118
• Device Catalogue Number: SBRD-18
• Device Lot Number: 971702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR