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

Model Number	CS-2001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Type of Reportable Event	Serious Injury
Event or Problem Description
The procedure was atrial flutter/fibrillation ablation.The atrial flutter was ablated and transseptal was performed.The patient's blood pressure dropped suddenly and the procedure was stopped.The patient was transferred to the icu.Patient had ecmo done later in the day.The ablation in the left atrium had not performed and circa had not clarified its position under x-ray prior the incident occurrence.Electrophysiologist stated that the circa probe was placed in the bronchus which caused hemorrhage.Anesthesiologist assistant stated that there was no evidence of the patient's bronchial hemorrhage.
Additional Manufacturer Narrative
No alleged defect with probe or instructions.User did not place under fluoroscopic x-ray.

• Brand Name: S-CATH ESOPHAGEAL TEMPERATURE PROBE
• Common Device Name: ESOPHAGEAL TEMPERATURE PROBE
• Manufacturer (Section D): CIRCA SCIENTIFIC; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer (Section G): CIRCA SCIENTIFIC; 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: 16881576
• Report Number: 3009437315-2023-00002
• Device Sequence Number: 20291155
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/05/2023

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: 04/06/2023
• Initial Report FDA Received Date: 05/05/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Unknown