Cortrak-assisted feeding tube insertion: A comprehensive review of adverse events in the maude database

Annette M. Bourgault, Lillian Aguirre, Joseph Ibrahim

Research output: Contribution to journalArticlepeer-review

28 Scopus citations


Background Electromagnetic devices to guide feeding tube placement such as the CORTRAK Enteral Access System have shown promising results; however, researchers in recent studies have expressed concern that a higher level of user expertise may be required for safe use. Objectives To review adverse events related to CORTRAKassisted feeding tube insertion reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Methods A retrospective, secondary analysis of the MAUDE database was performed to evaluate adverse events (ie, injury or death of patient) related to CORTRAK. Results Fifty-four adverse events between January 1, 2006 and February 29, 2016 were identified and reviewed. Most events (98%) involved feeding tube placement in the lungs (37%, left lung; 46%, right lung; 15%, not specified). Lung complications included pneumothorax (77%) and pneumonitis (21%). Death occurred in 17% of lung placements. Clinicians failed to recognize placement in 89% of CORTRAK insertion tracings reviewed. Conclusions Lung placement is not unique to CORTRAK and is an inherent risk of all feeding tube insertions. In known or suspected lung placement, feeding tubes should be removed and radiography performed to assess for pneumothorax. Clinicians must observe closely for lung placement and discriminate lung from gastric placement on insertion tracings. Clinicians require specialized training and experience to develop competency in using the CORTRAK device, although the exact amount of experience needed is unknown.

Original languageEnglish (US)
Pages (from-to)149-156
Number of pages8
JournalAmerican Journal of Critical Care
Issue number2
StatePublished - Mar 1 2017

ASJC Scopus subject areas

  • Critical Care


Dive into the research topics of 'Cortrak-assisted feeding tube insertion: A comprehensive review of adverse events in the maude database'. Together they form a unique fingerprint.

Cite this