Analysis of Reported Gastrostomy Tube Problems and Patient-related Adverse Events Using the FDA Manufacturer and User...

Gastrostomy tubes (G-tubes) are used for enteral nutrition in patients with swallowing disorders, neurological conditions, or other diseases requiring long-term nutritional support. They can be placed endoscopically, via percutaneous endoscopic gastrostomy technique using pull or push methods, or through fluoroscopic techniques. We aimed to analyze the range and frequency of G-tube-related adverse events (AEs) reported over the past decade.

We conducted a retrospective review of the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database to identify all G-tube AEs reported through January 2025. Each report included a unique identifier, event date, event type, event narrative, manufacturer, device brand, device problems, and patient-related AEs. When available, additional data such as device type and tube size were collected. Device problems were grouped into categories. Descriptive statistics, distribution, and trend analysis were performed.

A total of 1761 reports over 10 years were included in the analysis. Reported event types included malfunction in 71.3% (1255/1761), injury in 27.1% (478/1761), and death in 1.6% (28/1761), with most deaths attributed to peritonitis with or without sepsis. The most frequently reported device malfunctions were balloon damage in 17.1% (302/1761) of cases, detachment of the device or a component in 16.6% (293/1761), and device breakage in 12.8% (226/1761). The most frequently reported patient-related AE was insertion site infection in 7.0% (123/1761), followed by foreign body retention in 6.8% (120/1761). Balloon-related problems and fluid leaks were more commonly reported in button devices compared with nonbutton devices (P<0.001).

In this retrospective analysis of the FDA MAUDE database, reported gastrostomy tube-related device problems and patient-related AEs demonstrated distinct patterns. This analysis highlights device-specific vulnerability and failure modes from a postmarket surveillance perspective.