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	Hypothermia (1915)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a radiofrequency cardiac ablation procedure for atrial fibrillation and atrial flutter on (b)(6) 2023, and the ensoetm was used to cool the esophagus during the procedure.The patient was intubated with an endotracheal tube at approximately 7:58am local time, and the ensoetm was placed at approximately 8:27am.At approximately 11:00am, towards the end of the case, it was noted that the patient's blood pressure had decreased from a systolic pressure above 80mmhg to a systolic pressure below 60mmhg.Imaging on intracardiac echocardiography showed decreased ventricular contractility, prompting the administration of approximately 45 seconds of cardiopulmonary resuscitation, along with the administration of an epinephrine drip.The patient's vital signs improved, and she was transferred to the intensive care unit, where a foley catheter with temperature monitoring capability was placed, showing a temperature of 31°c.Upon review of anesthesia records, it was discovered the patient reached a minimum temperature of 29°c.However, the source of this temperature measurement (whether from nasopharyngeal, forehead, axillary, etc.) was not recorded, and the minimum temperature was not noticed or reported to the operating team.The patient was successfully extubated 3 to 4 hours afterwards and all vasopressors were stopped, indicating continued rapid improvement.After staying overnight in the intensive care unit, the patient was transferred to a standard hospital room and then discharged the following day in good condition.The patient fully recovered and had no further complications or sequelae.
Additional Manufacturer Narrative
Attached evaluation summary includes a dhr review and clinical assessment.Based on the provided information, the ensoetm likely contributed to the patient's hypothermia.However, a number of other factors also likely significantly contributed to the patient's hypothermia, including: the patient's existing hypothyroidism, the use of a beta-blocker, the use of amiodarone, a low starting temperature, and a decreased intensity of monitoring patient body temperature during the case.

• 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
• Manufacturer (Section G): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 3440 s dearborn st #215-south; chicago IL 60616
• Manufacturer Contact: erik kulstad ; 3440 s dearborn st #215-south; chicago, IL 60616 ; 8885344873
• MDR Report Key: 16401097
• Report Number: 3010412492-2023-00002
• Device Sequence Number: 17566305
• Product Code: PLA
• UDI-Device Identifier: 00857915006180
• UDI-Public: (01)00857915006180(17)250321(10)199118722
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 03/21/2025
• Device Model Number: ECD02-A
• Device Lot Number: 199118722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CINCINNATI SUB-ZERO SUB-ZERO BLANKETROL III
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 58 KG