This letter corrects the previously issued Dear Health Care Provider Letter from January 11, 2018
AUDIENCE: Surgery, Critical Care Medicine
ISSUE: The FDA is providing information about reports of pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems. Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death. Although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically < 0.5%, we are alerting clinicians that the use of this device does not eliminate this risk and reminding health care providers of important use information for EAS systems.
From January, 2012, to July, 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Cortrak device. These included 11 reports of patient death. The relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. In addition, because the MDR system is based on passive surveillance, we cannot determine how the rate of these complications compares to that estimated for blind insertion.
During that same period of time, FDA received one report of a non-fatal pneumothorax event associated with the Kangaroo Feeding Tube with IRIS Technology. (The previous letter issued on January 11, 2018 attributed an inaccurate number of adverse events and deaths to the Kangaroo Feeding Tube with IRIS Technology). That event occurred following blind placement of the tube, without use of the video console. The smARTrack device is not currently being sold within the United States and no MDRs have been received for this device.
BACKGROUND: EAS are designed to aid in the placement of naso-enteric feeding tubes by transmitting real-time positional information to an external visible screen or console. The FDA has cleared three EAS devices for marketing in the United States, each of which uses a different technology to track the position of the feeding tube during the insertion procedure.
- The Cortrak 2 Enteral Access System by Corpak Medsystems uses electromagnetic sensors in a stylet to provide a visual representation of the tip of the tube relative to an external receiving unit placed over the patient’s xiphoid process.
- The Kangaroo Feeding Tube with IRIS Technology by Covidien employs a camera embedded in the distal end of the tube and provides a video stream of the gastrointestinal tract during placement.
- The smARTrack Feeding Tube by ART Healthcare uses impedance sensors embedded within the feeding tube to provide a visual representation of the tube relative to the lower esophageal sphincter.
RECOMMENDATION: For Enteral Access Systems, the FDA recommends:
- The device only be used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
- The device not be used in patients who have contraindications for naso-enteric feeding tubes in general.
- If any resistance is met during placement or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed.
- Confirmation of the final tube position should be done per institution protocol, in particular if:◦Any difficulty occurred during insertion;
- The patient displayed any signs of respiratory distress during or after the procedure;
- The tube’s path during placement appeared to deviate from expected or the final location is uncertain;
- The patient has a variation in normal gastrointestinal anatomy; or
- The patient is intubated or has an altered level of consciousness.
For the Cortrak device in particular, the FDA also recommends:
- The user ensures that the receiver is aligned properly throughout the procedure and does not move. The manufacturer instructions call for the top of the receiver to be positioned at the xipho-sternal junction, level, and parallel with spine and midline.
- The user observes and assesses the real-time tracing to ensure the proper path of the tube. The final location, including which quadrant the tip is located in, and the centimeter marking, should not be solely relied upon for assessment of whether the device is correctly placed or not.
- The device be used with caution in proximity to other electrical equipment (especially those emitting in the 20-300 kHz frequency band) as readings may be impacted.
Prompt reporting of adverse events helps the FDA identify and better understand the risks associated with medical devices. Voluntary reports of adverse events related to EAS devices can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable MDR regulations. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.