MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for S-CATH ESOPHAGEAL TEMPERATURE PROBE CS-2001 manufactured by Circa Scientific.
[174729412]
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.
Patient Sequence No: 1, Text Type: N, H10
[174729413]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009437315-2020-00001 |
| MDR Report Key | 9578687 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2019-12-14 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRED PIAZZA |
| Manufacturer Street | 14 INVERNESS DRIVE EAST SUITE H-136 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 3039518767 |
| Manufacturer G1 | CIRCA SCIENTIFIC |
| Manufacturer Street | 14 INVERNESS DRIVE EAST SUITE H-136 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-CATH ESOPHAGEAL TEMPERATURE PROBE |
| Generic Name | ESOPHAGEAL TEMPERATURE PROBE |
| Product Code | FLL |
| Date Received | 2020-01-10 |
| Model Number | CS-2001 |
| Catalog Number | CS-2001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCA SCIENTIFIC |
| Manufacturer Address | 14 INVERNESS DRIVE EAST SUITE H-136 ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-10 |