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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the provided information, the exact cause of the patient's bleeding cannot be conclusively determined.Potential factors that could have contributed to or caused this patient's bleeding include: (1) oropharyngeal trauma from a difficult intubation, (2) pre-existing esophagitis, or (3) the use of procedural anticoagulation.Furthermore, the ensoetm could have caused or contributed to the patient's bleeding by abrading esophageal mucosa that had been compromised by pre-existing esophagitis.
Event or Problem Description
The patient underwent a radiofrequency cardiac ablation procedure to treat their atrial fibrillation on (b)(6) 2023.The patient was placed under general anesthesia and was intubated with a standard endotracheal tube.Intubation was performed by a trainee who experienced difficulty completing the intubation and required multiple attempts to place the endotracheal tube.The ensoetm was successfully placed into the esophagus without difficulty, and the procedure was completed without incident.Upon withdrawal of the ensoetm after the end of the procedure, a small amount of blood was discovered in the oropharynx.The source of the blood was unclear, but it was initially presumed to be from oropharyngeal trauma from the difficult intubation.As a result, the clinical team elected to keep the patient endotracheally intubated while further evaluation was undertaken in the intensive care unit (icu).In the icu over the following day, the patient had a ct scan of the chest, showing a diffusely thickened esophagus suggestive of esophagitis.An endoscopy showed evidence of oropharyngeal trauma, but without a clear source of any bleeding and no esophageal perforation.In the distal esophagus a small tear was discovered that was not bleeding, but it was suspected this tear could have been the source of blood seen previously in the oropharynx.No treatment was required, and no further evidence of bleeding was discovered.The patient was successfully extubated, fully recovered, and discharged the next day with anticoagulation restarted.

• Brand Name: ENSOETM
• Common Device Name: ESOPHAGEAL THERMAL REGULATION DEVICE
• Manufacturer (Section D): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 180 n. wabash ave. #601; chicago IL 60601
• Manufacturer (Section G): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 180 n. wabash ave. #601; chicago IL 60601
• Manufacturer Contact: erik kulstad ; 180 n. wabash ave. #601; chicago, IL 60601
• MDR Report Key: 18093050
• Report Number: 3010412492-2023-00005
• Device Sequence Number: 6753938
• Product Code: PLA
• UDI-Device Identifier: 00857915006180
• UDI-Public: (01)00857915006180(17)260220(10)199115223
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: 02/20/2026
• Device Model Number: ECD02-A
• Device Lot Number: 199115223
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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/GENTHERM BLANKETROL III.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG