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

Model Number CS-2001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 12/14/2019

Event Type  Injury  

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 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
• 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: 9578687
• MDR Text Key: 174729412
• Report Number: 3009437315-2020-00001
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10860237000207
• UDI-Public: 10860237000207
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2001
• Device Catalogue Number: CS-2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2019
• 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): Required Intervention