MAUDE Adverse Event Report: ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ENSOETM; ESOPHAGEAL THERMAL REGULATION DEVICE

Model Number	ECD02-A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Notification: a company representative was informed about this incident during a routine in-service visit on (b)(6) 2018 from a nurse in the neurological icu.The nurse said the incident occurred "a few months ago".Device investigation: the device was returned for investigation on (b)(6) 2018 and was inspected by attune medical, senior director of operations, (b)(6).The device showed no signs of damage or deficiency and functioned correctly when connected to a blanketrol ii heat exchanger.The device did not contain any sharp edges, and the stiffness of both the main body of the device and the distal tip were similar to a typical production device.The investigation of the device did not reveal any device defects or non-conformances that may have contributed to the esophageal tear.Clinical investigation: attune medical clinical expert, dr.(b)(6), was consulted on the details of this incident.Because this incident involved a severely injured, intubated, poly-trauma patient with extensive cranio-facial injuries sustained from high-speed blunt trauma, it is difficult to determine both the timing and the etiology of the esophageal injury.The severity of the patient's injuries allow the distinct possibility that esophageal injury, along with other bone or organ injuries seen with severe blunt trauma, occurred as a result of the significant forces sustained during the patient's initial impact.Rapid deceleration is known to result in a variety of internal organ injuries, including solid organs (liver, spleen, kidney, etc.) and hollow organs (intestine, esophagus, bladder, etc.).As such, the patient's esophagus may have been damaged or torn prior to the patient's arrival to the neuro icu.Additionally, the esophageal injury may have been caused by placement of either the endotracheal or the orogastric tube, both of which were placed prior to the ensoetm.Finally, a small esophageal injury may have been exacerbated by placement of the ensoetm into an esophagus with an orogastric tube already in place.Labeling investigation: the dhr for lot #199100918a was reviewed to determine the version of the ifu that was used to manufacture this lot.(b)(4) instructions for use was used to manufacture this lot.(b)(4) contains the following warnings/precautions that may be relevant to this incident: (1) "the ensoetm may cause or exacerbate esophageal tissue damage in patients with known esophageal deformity or evidence of esophageal trauma." and (2) "dual placement of other devices in the esophagus with the ensoetm is an unintended use and may result in patient harm." insertion of the ensoetm into a patient with evidence of esophageal trauma is a known risk, and clinicians are appropriately warned that insertion of the ensoetm into these patients may cause additional harm.Furthermore, dual placement of devices in the esophagus (e.G.Attempting to place an ensoetm in patients with an orogastric tube already in place) is a known risk, and clinicians are warned that this action may cause patient harm.Conclusion the exact cause of, or the timing of, the esophageal injury is unable to be determined from the information available.The esophageal injury may have been present prior to the patient's arrival at the neuro icu, it may have been caused or exacerbated by insertion of the endotracheal tube or orogastric tube, and/or it may have been caused or exacerbated by dual placement of the ensoetm with an orogastric tube.If the ensoetm contributed to the esophageal tear, the cause was most probably user error due to both the insertion of the ensoetm into a patient with severe craniofacial trauma (and the consequent potential for esophageal injury) and the insertion of the ensoetm into a patient with an orogastric tube already in place.
Event or Problem Description
The patient arrived at the neuro icu with severe craniofacial trauma described as occipital bone fracture, bilateral sphenoid fracture, first maxillary incisor fracture, temporal bone fracture extending into temporomandibular joint, and nasal bone fractures.These injuries were caused by jumping out of a car traveling approximately 50 mph.The patient was initially intubated with an endotracheal tube and a standard orogastric tube was placed.A nurse subsequently attempted to place the ensoetm without removing the orogastric tube.The nurse experienced some difficulty placing the ensoetm, but was able to successfully place the device.After several hours, the neuro icu staff noticed crepitus in the neck area.Upon inspection, they discovered an injury, described as a "tear" to the esophagus.Medical intervention was required to clip the tear.The patient survived the incident and was later discharged from the neuro icu.

• Brand Name: ENSOETM
• Common Device Name: ESOPHAGEAL THERMAL REGULATION DEVICE
• Manufacturer (Section D): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 3440 s dearborn st #215-south; chicago IL 60616
• MDR Report Key: 7953505
• Report Number: 3010412492-2018-00001
• Device Sequence Number: 1531123
• Product Code: PLA
• UDI-Device Identifier: 00857915006050
• UDI-Public: (01)00857915006050(17)200913(10)199100918A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K172493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: ECD02-A
• Device Lot Number: 199100918A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR