MAUDE Adverse Event Report: CIRCA SCIENTIFIC, INC. S-CATH ESOPHAGEAL TEMPERATURE PROBE

Model Number	CS-2001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician asked us to report the occurrence of a patient who had an esophageal fisula following an rf ablation.Circa was used to monitor esophageal temperature.Patient has since recovered.Tee probe was also used on patient for watchman insertion.
Additional Manufacturer Narrative
Atrioesophageal fistula is uncommon but has been reported with all approaches to atrial fibrillation ablation, without clearly identifiable predisposing factors.Probe was discarded by the hospital after use and therefore no inspection of the complaint probe could be performed.Lot number not available as the probe and packaging had been discarded by the hospital after use.No deficiency or malfunction with the temperature monitoring system was reported by the hospital.The circa temperature probe is placed in the esophagus and the continuous esophageal temperature data is displayed on the circa monitor.The interpretation and use of this data is a the sole discretion of the physician.
Additional Manufacturer Narrative
Atrioesophageal fistula is uncommon but has been reported with all approaches to atrial fibrillation ablation, without clearly identifiable predisposing factors.Probe was discarded by the hospital after use and therefore no inspection of the complaint probe could be performed.Lot number not available as the probe and packaging had been discarded by the hospital after use.No deficiency or malfunction with the temperature monitoring system was reported by the hospital.The circa temperature probe is placed in the esophagus and the continuous esophageal temperature data is displayed on the circa monitor.The interpretation and use of this data is a the sole discretion of the physician.
Event or Problem Description
Physician asked us to report the occurrence of a patient who had an esophageal fisula following an rf ablation.Circa was used to monitor esophageal temperature.Patient has since recovered.Tee probe was also used on patient for watchman insertion.

• Brand Name: S-CATH ESOPHAGEAL TEMPERATURE PROBE
• Common Device Name: ESOPHAGEAL TEMPERATURE PROBE
• Manufacturer (Section D): CIRCA SCIENTIFIC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer (Section G): CIRCA SCIENTIFC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 13602629
• Report Number: 3009437315-2022-00003
• Device Sequence Number: 20291989
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112376
• 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): 02/25/2022

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 Model Number: CS-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: RF ABLATION, TEE PROBE, AND WATCHMAN DEVICE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown