MAUDE Adverse Event Report: FIAB S.P.A. SENSITHERM PROBE; ESOPHAGEAL CATHETER FOR TEMPERATURE MEASUREMENT

Model Number 26155ST

Device Problem Failure to Advance (2524)

Patient Problem Epistaxis (4458)

Event Date 05/05/2023

Event Type  Injury  

Event Description

During the af ablation procedure, the user set up the temperature monitoring probe (26155st lot 23cb0078) in nasal cavity but that was a failure.They tried to place the probe orally, but an epistaxis appeared.At the end of the procedure, the epistaxis intensified requiring an embolization to stop the bleeding.The patient had to be moved to intensive care.

Manufacturer Narrative

1.The event occurred in eu (france) not in us.2.The product reported involved in the incident - model 26155st - is similar to the product cleared for the marketing in us under the 510(k) k123361 and model 26155s/us, however this latter is not sold in the us since 2019 and currently dismissed in fiab portfolio.3.The sample of the device involved in this incident is not available yet, but is being returned to fiab for examination.The preliminary assessment is based on the available information and it's expected to be confirmed after the device return, unless the returned probe will show severe defectiveness / non compliance with expected specifications (i.E.From a dimensional standpoint or the presence of anomalies on shape, presence of sharp edges etc).4.It is deemed not correct identifying the probe 26155st itself as the cause of the epistaxis event, instead of considering the epistaxis as a possible and expected occurrence during any kind of tool introduction inside a highly vascularized body area.There is no inherent characteristic of the probe 26155st itself that can cause damage other than its friction against delicate tissues caused by a rough introduction or previously.Moreover the information from the healthcare facility indicates that the patient was under anti-coagulant treatment and this is a key factor that can prolonge / increase the epixtasis.

• Brand Name: SENSITHERM PROBE
• Type of Device: ESOPHAGEAL CATHETER FOR TEMPERATURE MEASUREMENT
• Manufacturer (Section D): FIAB S.P.A.; via paolo costoli 4; vicchio, firenze, italy 50039 ; IT 50039
• Manufacturer Contact: francesco batistini ; via costoli 4; vicchio, florence,tuscany 50039 ; IT 50039
• MDR Report Key: 17287621
• MDR Text Key: 318684877
• Report Number: 3003072803-2023-00002
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 26155ST
• Device Lot Number: 23CB0078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male