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

Model Number CS-2001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 10/01/2021

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 286152667
• Report Number: 3009437315-2022-00003
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RF ABLATION, TEE PROBE, AND WATCHMAN DEVICE
• Patient Outcome(s): Hospitalization