MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT0.25F6-450

Device Problem Gas/Air Leak (2946)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Swelling/ Edema (4577)

Event Date 08/28/2023

Event Type  Injury  

Event Description

A user facility reported that a patient had experienced superficial (1-2 degree) burns on their eyelids immediately following a thermage flx treatment in spain.It was clarified the injury was a superficial burn on the patient¿s lower eyelid, in the lateral exterior left location.The patient was administered topical emla and clorirofta dual anesthetic prior to the procedure.Solta medical branded cryogen and 1 bottle of coupling fluid was used with the highest level of treatment at 4.5.During treatment, the provider observed cryogen coming out of the handpiece stronger than normal and had caused a freezing sensation on the patient¿s eyelashes.The patient reported pain around 430 pulses.This was the first time the treatment tip was used, and the provider checked the tip prior to the procedure, and at 225 pulses, with no discrepancies found.The day after the procedure, the patient reported there were small burns on their eyelids.The provider prescribed matricium ampoule every 12 hours, silkes application every 3-4 hours, cicabio with spf 50 and growth factor eye serum.The patient had not undergone any procedure in the same symptom area on the treatment day or within 90 days prior.A solta medical reviewer examined pictures of the patient injury.Erythema and inflammation were visible on patient¿s cheek with edema on the lower eyelid.On a picture with one side of the patient¿s face, two red papules could be seen on the cheek next to the nose.The patient outcome is unknown at this time.

Manufacturer Narrative

The data log and handpiece have been requested to be returned for evaluation.The data log was reviewed and based on available information the system and handpiece performed as expected.The handpiece has not been returned to date.The investigation is ongoing.

Manufacturer Narrative

The data logs, handpiece, and treatment tip were returned for evaluation.The data logs from the event showed some errors occurred during the event.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece perform as expected.The handpiece was evaluated and service was unable to verify cryogen delivery issues reported by the customer.Cryogen flow and release fell within specification.During handpiece inspection it was discovered the nose assembly was corroded with flattened pogo pins, the vibration assembly was damaged and return pad clip has fallen apart.All these parts were replaced.None of these additional handpiece issues caused the reported cryogen complaint.The treatment tip from the event was evaluated.The tip passed thermistor and leak testing, and no discrepancies were observed upon visual inspection.No functional test could be performed due to the tip being expired.According to the thermage flx user manual, burns are a known possible side effect during a thermage flx treatment.The procedure produces heating in the upper layers of the skin, and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial number.Based on the available information, burns are a known possible side effect during a thermage flx treatment.No corrective action is necessary at this time.

Manufacturer Narrative

Due to internal review it was concluded the report for this event should have been documented against the treatment tip and not the handpiece.The conclusions of our previous submission remain unchanged.Corrections: d4: model: from "th-6r" to "tt0.25f6-450".Serial: from "(b)(6)".H4: device manufacture date: from "10/1/2019" to "12/07/2022".H5: labeled for single use?: from "no" to "yes".H8: usage of device: from "reuse" to "initial".

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17821127
• MDR Text Key: 324301262
• Report Number: 3011423170-2023-00084
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2023

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
• Device Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2023; 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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
• Treatment: TOPICAL EMLA+COLIROFTA DUAL ANAESTHETIC.
• Patient Sex: Female