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

Model Number 70-0041-116

Device Problem Material Rupture (1546)

Patient Problem Feeding Problem (1850)

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

A1-a6) patient information details were not available from initial reporter.D4) model number is xeridiem part number; catalog number is exclusive distributor part number that appears on label.G6) this is late filing of an initial report as filing was missed after submission of france vigilance report.H6) the device was returned to xeridiem for evaluation.A physical evaluation confirmed the unit to have a balloon rupture as indicated in the complaint.Due to device usage, further evaluation could not be performed beyond the balloon defect confirmation.Possible factors that affect product performance and balloon life include device handling, packaging, shipping, storage, cleaning, over-inflation, the liquid used to inflate the balloon of the device, maintenance, and unique patient factors such as diagnosis, treatment, surgical procedures, as well as medications, nutrition formulas, and gastric ph.Some patients also ingest food orally when the device is still in place which could also impact the balloon performance of the device.

Event Description

Rupture of the gastrostomy tube balloon 3 days after insertion.Retraction of the probe at the level of the wall with passage of nutrition intraparietal.Patient status; had major clinical deterioration with septic risk but subsequently recovered fully.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 17921510
• MDR Text Key: 325508356
• Report Number: 2025851-2023-00002
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0041-116
• Device Catalogue Number: SBRD-16
• Device Lot Number: 10716C001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention