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

Model Number CS-46EP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Probe was discarded by the hospital after use and therefore no visual inspection of the complaint probe could be performed.The manufacturer performed a review of the device history records, labelling and evaluation of a sample probe from released stock, engineering change review, design review and communication with the physician and circa scientific clinical advisor.There was no identified labelling problem or product change or defect that would attribute to the oesophageal haematoma.Reason for haematoma is indeterminate as it may have been a combination of other procedure (tee), patient anatomy, and unknown resistance during probe insertion.

Event Description

S-cath m probe used during routine pvi with medtronic achieve cryo balloon.Tee performed pre-procedure, with sore throat reported post tee, otherwise unremarkable.Immediately post waking from pvi patient reported chest pain.Dismissed initially as typical post procedure pain.One day post procedure patient continued to report chest pain with blood in stool and reduced haemoglobin.Gastroscopy performed showing "long hemi-circumferential haematoma ! half the lumen".Physician reported unremarkable cs-46ep probe insertion except for possibly some resistance in the last ¼ of insertion but nothing that was alarming.Probe was discarded after case before issue was identified.

• Brand Name: S-CATH M 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 80129
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 12178326
• MDR Text Key: 261911161
• Report Number: 3009437315-2021-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: CS-46EP
• Device Catalogue Number: CS-46EP
• Device Lot Number: 12590-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2019
• 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