MAUDE Adverse Event Report: FIAB SPA ESOTEST MULTI ESOPHAGEAL TEMPERATURE PROBE AND MONITORING SYSTEM; TEMPERATURE MONITORING PROBE

Model Number	2617376H/US
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Gastroesophageal Burn (4475)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The injury, esophageal transmural lesion, is a not infrequent complication of the cardiac af ablation procedure using an ablation catheter and rf generator.Causes can be also associated to pre-existing lesions / damages to the esophageal mucosa due to the patient's conditions or previous clinical treatments.The specific cause of the esophageal transmural lesion in this case is not known.The device esotest multi probe is a probe part of a temperature measurement system that has no active part in the ablation procedure.No malfunctions of the device have been reported during use.Although the sample of the device was discarded and not available for examination, the temperature data recorded by the esotest monitor during its use show that the probe sensed a higher temperature on the most distal temperature sensor t1 (the first one of the seven temperature sensors t1.T7 placed on a sensor's array) during the ablations performed.This indicates that: a) the probe functioned as expected in measuring temperature; b) the higher temperature was on the side of the distal end of the probe and c) the temperature gradient of the sensors, increasing towards t1, suggests that the point of greatest thermal increase was beyond the area covered by the sensors array, beyond t1 and in this area the temperature increase may have been even much higher.
Event or Problem Description
The physician identified an esophageal lesion, describing it a 'transmural lesion' 2-3 weeks post an af ablation procedure.The rf ablation procedure was performed using a biosense webster ablation and mapping system.The esotest multi probe was used during the procedure to monitor esophageal temperature.

• Brand Name: ESOTEST MULTI ESOPHAGEAL TEMPERATURE PROBE AND MONITORING SYSTEM
• Common Device Name: TEMPERATURE MONITORING PROBE
• Manufacturer (Section D): FIAB SPA; via costoli, 4; vicchio, 50039 ; IT 50039
• MDR Report Key: 11310646
• Report Number: 3003072803-2021-00001
• Device Sequence Number: 17051640
• Product Code: FLL
• UDI-Device Identifier: 08054953343884
• UDI-Public: 08054953343884
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 09/30/2024
• Device Model Number: 2617376H/US
• Device Lot Number: 20CB0588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/10/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 62 YR