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. Objectives 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.

Cateterização gástrica em recém-nascidos prematuros: análise de prevalência das técnicas de mensuração [Gastric tube insertion in preterm infants: prevalence analysis of measurement techniques] [Cateterización gástrica en neonatos prematuros: análisis de prevalencia de las técnicas de medición]

“…Os riscos envolvem três contextos de possíveis erros de posicionamento: colocação pulmonar -pneumotórax e pneumonias; colocação alta (esôfago) -broncoaspiração e pneumonias; e colocação baixa (pós-pilórica) -problemas de absorção intestinal e intolerância alimentar, além disso dificuldade no trajeto podem causar traumas e lesões perfurativas no trato gastrintestinal ou respiratório. Em qualquer destas situações a morte é um risco potencial 5,11,[16][17][18][19] .…”

Improved Safety and Efficacy of Small‐Bore Feeding Tube Confirmation Using an Electromagnetic Placement Device

“…Recently some published articles have questioned the safety of the EMPD device and support continued use of abdominal radiographic verification . However, a retrospective review of the Food and Drug Administration's Manufacturer and User Facility Device Experience database found most misplacements to be from user error and misinterpretation by the clinician, not equipment related . This supports the need to further elucidate appropriate training and competency assessment when using an EMPD.…”

Varying levels of fidelity on psychomotor skill attainment: a CORTRAK product assessment

“…The most frequent complication is insertion of the FT into the pulmonary system, which can lead to pneumothorax, pneumonitis and death 2. CORTRAK Enteral Access System (EAS) is an electromagnetic device that has the benefit of providing real-time visualisation during the FT insertion.…”

“…CORTRAK Enteral Access System (EAS) is an electromagnetic device that has the benefit of providing real-time visualisation during the FT insertion. Research on CORTRAK-assisted FT insertion has shown positive outcomes through the use of specially trained superusers, which are most frequently registered nurses 2. Unfortunately, there is no evidence to suggest the ideal amount or type of training required by superusers.…”