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

Model Number CS-2001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bronchial Hemorrhage (4456)

Event Type  Injury  

Event 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.

Manufacturer Narrative

No alleged defect with probe or instructions.User did not place under fluoroscopic x-ray.

• Brand Name: S-CATH ESOPHAGEAL TEMPERATURE PROBE
• Type of Device: 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
• MDR Text Key: 314709830
• Report Number: 3009437315-2023-00002
• 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: 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
• Device Operator: Health Professional
• Device Model Number: CS-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/05/2023
• 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
• Patient Outcome(s): Life Threatening; Hospitalization