title: Cortrak-Assisted Feeding Tube Insertion: A Comprehensive Review of Adverse Events in the MAUDE Database.
abstract: 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.
  
  
  OBJECTIVE
  To review adverse events related to CORTRAK-assisted 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.
authors.affiliation: Annette M. Bourgault is an assistant professor, University of Central Florida, College of Nursing, and a nurse scientist, Orlando Health, Orlando, Florida. Lillian Aguirre is a clinical nurse specialist in trauma critical care, Orlando Regional Medical Center, a part of Orlando Health, Orlando, Florida. Joseph Ibrahim is trauma medical director and associate program director, Orlando Regional Medical Center, a part of Orlando Health. annette.bourgault@ucf.edu.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Bourgault
authors.affiliation: Annette M. Bourgault is an assistant professor, University of Central Florida, College of Nursing, and a nurse scientist, Orlando Health, Orlando, Florida. Lillian Aguirre is a clinical nurse specialist in trauma critical care, Orlando Regional Medical Center, a part of Orlando Health, Orlando, Florida. Joseph Ibrahim is trauma medical director and associate program director, Orlando Regional Medical Center, a part of Orlando Health.
authors.forename: Lillian
authors.initials: L
authors.lastname: Aguirre
authors.affiliation: Annette M. Bourgault is an assistant professor, University of Central Florida, College of Nursing, and a nurse scientist, Orlando Health, Orlando, Florida. Lillian Aguirre is a clinical nurse specialist in trauma critical care, Orlando Regional Medical Center, a part of Orlando Health, Orlando, Florida. Joseph Ibrahim is trauma medical director and associate program director, Orlando Regional Medical Center, a part of Orlando Health.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ibrahim
mesh_terms: D057785:Catheters / Q000009:adverse effects*; D004750:Enteral Nutrition / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007441:Intubation, Gastrointestinal / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D011030:Pneumothorax / Q000209:etiology*; D011859:Radiography / Q000295:instrumentation* / Q000379:methods; D012189:Retrospective Studies