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

Model Number	CS-2001
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No specific testing could be performed on the complaint probe as it had been discarded by the hospital.A probe from released stock was evaluated by visual inspection and dimensional measurement.The tip is rounded and smooth with no defects observed.Probe and stylet dimensions were measured and all were within specification.Stylet was fully inserted and probe was flexible with no indication of undue stiffness.A review of probe specifications and engineering changes show no changes to the probe materials, diameters, thickness, etc.Based on evaluation of sample from released stock and engineering change review, there is no product change or defect that would attribute to the esophageal perforation.Cleveland clinic communicated that the situation was likely due to unusual finding of patient's esophagus.Physician has seen the images taken during the procedure and said that the esophagus appeared to have an folds in the esophagus.It was described in a way to indicate that this was an unusual finding.Patient may also have had a double lumen.
Event or Problem Description
Esophageal perforation.Patient underwent surgery and was treated with an esophageal stent.Esophagus had two holes, described by physician as being about 8f as if the probe had gone out of the esophagus and then back into the esophagus.Circa used to monitor temperature during a cardiac ablation procedure about 2 weeks prior.There was no thermal injury to the esophagus.

• 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
• MDR Report Key: 9578687
• Report Number: 3009437315-2020-00001
• Device Sequence Number: 13535112
• Product Code: FLL
• UDI-Device Identifier: 10860237000207
• UDI-Public: 10860237000207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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
• Device Catalogue Number: CS-2001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention