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

Model Number CS-2001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Probe was misplaced in bronchus rather than esophagus.There is no defect or malfunction of the device.User error - fluoroscopy was not used during probe placement.Device ifu states to use fluoroscopy during probe placement.

Event Description

Dr.Reports a patient lung perforation caused by circa probe.Patient coughed up blood for five days, then recovered.No fluoroscopy was used in the procedure.

• 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; suite h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 14311468
• MDR Text Key: 290947467
• Report Number: 3009437315-2022-00004
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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: 04/06/2022
• 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
• Patient Outcome(s): Hospitalization