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

Model Number	ECD02-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a left atrial ablation procedure on monday, (b)(6) 2024.The ensoetm was placed successfully without difficulty, and proper position was confirmed.The procedure was completed successfully.At the time of planned discharge the next morning, the patient felt lightheaded, prompting additional workup.The patient's hemoglobin was found to be low (4.9 g/dl, from a previous level of 12 g/dl), but the patient did not have hematemesis, melena, or any other additional symptoms at this time.A ct angiogram of chest, abdomen, and pelvis was negative for any etiology.The patient received a transfusion of a total of 5 units of packed red blood cells and subsequently developed melanotic stools, but did not experience any hematemesis.On (b)(6) 2024, an esophagogastroduodenoscopy (egd) was performed which showed a superficial ulcer at the distal third of the esophagus with stigmata of recent bleeding, and blood in the stomach.The location of the lesion in relation to anterior/posterior dimension of the esophagus was uncertain on initial imaging, and gastroenterology could not define the circumferential location of the lesion.The site had no active bleeding visible, but a clip was placed under the presumption that this was the source of blood loss.The patient was monitored for an additional 2 days in the hospital, and remained stable, with no further evidence of blood loss.The patient was discharged and returned for follow-up on (b)(6) 2024, where they were found to be doing well.A second follow-up on (b)(6) 2024 included an egd which showed no new findings.The patient continues to recover without incident.
Additional Manufacturer Narrative
Based on the provided information, the exact cause of the patient's superficial ulcer at the distal third of the esophagus with stigmata of recent bleeding cannot be conclusively determined.The reporting facility stated the ensoetm was successfully placed and the ablation procedure was performed without incident.The atraumatic nature of the ensoetm (with soft, medical grade silicone) is unlikely to have caused or contributed to an esophageal ulcer but cannot be conclusively ruled out.The patient continues to recover without further incident.

• Brand Name: ENSOETM
• Common Device Name: ESOPHAGEAL THERMAL REGULATING 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: 18842104
• Report Number: 3010412492-2024-00001
• Device Sequence Number: 12622234
• Product Code: PLA
• UDI-Device Identifier: 00857915006180
• UDI-Public: 00857915006180
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/04/2024

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 Model Number: ECD02-A
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 BLANETROL III.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic