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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypervolemia (2664)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attune medical determined it is reasonable to conclude that (1) it is unlikely the ensoetm contributed to the patient's intravascular volume in a clinically significant way, (2) the ensoetm did not malfunction due to its design or manufacturing processes, and (3) the leak in the ensoetm was most likely caused by a sharp object located in or around the patient's mouth during placement or use of the device.
Event or Problem Description
The patient received a radiofrequency cardiac ablation procedure for atrial fibrillation on (b)(6) 2022.An ensoetm was inserted to the cool the patient's esophagus during the procedure.The device was inspected for leaks prior to insertion, and no leaks were noted prior to insertion.After insertion, a small amount of fluid was noted in the patient's mouth.At this time, the ensoetm was partially removed from the esophagus and inspected for leaks, and a "small trickle" of water was noted.However, this fluid was initially believed to be oral secretions from the mouth and the ensoetm was replaced.Upon re-inserting the ensoetm in the esophagus, more fluid was noted in the patient's mouth, and the ensoetm was again removed and inspected for leaks.At this time, a steady stream of water was noted to be leaking from the side of the tube near the location on the device where the patient's mouth was located.The leaking ensoetm was replaced with a new ensoetm, and the remainder of the ablation procedure proceeded without incident.Following the procedure, the patient was held in the hospital to allow a sufficient number of hemodialysis sessions to restore the patient to their optimal weight and hemodynamic status.These sessions were pre-planned due to the patient's baseline congestive heart failure, end stage renal disease, and missed hemodialysis sessions, combined with the fluid added to the patient's circulation via the irrigation of the radiofrequency catheter.Following the pre-planned hemodialysis sessions, the patient was successfully discharged in good condition.

• 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: 14048358
• Report Number: 3010412492-2022-00001
• Device Sequence Number: 5440182
• Product Code: PLA
• UDI-Device Identifier: 10857915006187
• UDI-Public: (01)10857915006187(17)240603(10)199123521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 06/03/2024
• Device Model Number: ECD02-A
• Device Lot Number: 199123521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 BLANKETROL III; CINCINNATI SUB-ZERO BLANKETROL III
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 115 KG