MAUDE Adverse Event Report: CIRCA SCIENTIFIC, INC. MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE

Model Number	CS-31EP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned matrix12 m probe met dimensional specifications and no defects observed that would cause difficult placement.Root cause is indeterminate, it is not known why user experienced difficult placement.
Event or Problem Description
Anesthesia stated difficult placement with matrix12 m probe.Probe thought to be in esophagus, deployed and placement found to be in bronchial stem.Bleeding occurred.Nothing unusual about anatomy according to anesthesia & staff.The lab also stocks s-cath m.This was used after matrix12 m was removed.They extubated successfully after the case was finished using s-cath m.

• Brand Name: MATRIX12 M 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 SCIENTIFIC, 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: 21724964
• Report Number: 3009437315-2025-00001
• Device Sequence Number: 18514573
• Product Code: FLL
• UDI-Device Identifier: 10851498007135
• UDI-Public: 10851498007135
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222311
• 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): 03/28/2025

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-31EP
• Device Lot Number: 14659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown