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 10/06/2022

Event Type  Death  

Manufacturer Narrative

This was reported by rf ablation company, (b)(6).Circa contacted the hospital.Hospital stated that they determined no cause or origin of injury from equipment.Root cause was not the equipment used during procedure.Hospital had no knowledge of (b)(6) letter to the fda.

Event Description

During an atrial fibrillation (pvi) procedure, an esophageal perforation causing sepsis in the patient.The temperature monitoring device was alarming above the manufacturer's recommended high usage suggestions.The patient was admitted 17 days post procedure due to sepsis caused from an esophageal perforation the (sic) likely occurred during the ablation procedure.Per ct: mediastinum and lymphatic, there was pneumomediastinum, with air anterior to the esophagus at the level of the right main pulmonary artery, and expending inferiorly along the posterior margin of the left atrium.It is suspected to arise from esophageal perforation at the level of the mid esophagus.

• 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 SCIENTIFIC, INC.; 14 inverness drive east; h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 16390702
• MDR Text Key: 309731824
• Report Number: 3009437315-2023-00001
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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
• Date Manufacturer Received: 01/19/2023
• 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: ABBOTT RF ABLATION
• Patient Outcome(s): Death