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

Model Number TT4.00F6-900

Device Problems Insufficient Information (3190); Excessive Heating (4030)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537); Localized Skin Lesion (4542)

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that a patient experienced a second degree burn with blister to the left face and jawline after a thermage flx treatment of the face and neck.No other treatments had been performed in the same treatment area within the prior 90 days.The patient had no history of aesthetic treatments.The patient was provided with superficial anesthetic prior to the treatment.The incident occurred at around 200 reps, and a new cryogen canister was placed.The highest energy level used was 2.0.The reporter indicated that something out of the ordinary was observed during the treatment but did not specify what was observed.Solta cryogen and 40 ml solta coupling fluid were used for the treatment.The treatment tip was inspected prior to use and every 7 pulses throughout the treatment, with nothing atypical observed.Artificial skin and antibiotic were administered as secondary intervention to the adverse event.The patient¿s status at the time of reporting was that the patient had resolving blisters with some scabs remaining.No permanent damage or scarring is expected.The solta medical reviewer assessed this case as serious due to the requirement of treatment beyond the standard of care.

Manufacturer Narrative

The investigation is underway.

Manufacturer Narrative

A review of event datalogs showed the following error messages: quantity - error id - description - percent of reps 3 - ec485 - err_treatment_tip_too_cold - 0.33% 1 - ec781 - err_activation_button_timed_out - 0.11% 17 - ec785 - err_treatment_tip_lifted_prematurely - 1.89% 114 - ec78c - err_treatment_tip_temp_high - 12.67% the system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.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.The review of the system/data logs does not indicate that there is any handpiece or system issue present.Thermistor readings fluctuated during treatment indicating possible technique issues.It is recommended that the user verify proper treatment technique, position, and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).The handpiece must be perpendicular to the ground at the time of the treatment.The data log shows at least one of the thermistors around zero degree c, sometimes two of the thermistors, which indicates that the handpiece is tilted and not all four of the thermistors are touching the skin.The datacard log confirmed the customer¿s account of tip too warm (ec78c) occurring during treatment.If a treatment tip¿s thermistors exceed the maximum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a ¿tip too warm¿ events and place the system into a safe state.This condition presents no patient risk.The treatment tip was returned for evaluation.The tip passed leak testing and thermistor testing.Visual inspection passed, as there were no dents, scratches, blemishes, or dielectric breakdown observed.Functional testing was unable to be performed due to the tip being expired.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.According to thermage flx user manual, burns and blisters are known possible side effects 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.Based on the available information, the most probable root cause is that burns and blisters are known possible side effects during thermage flx treatment.It was reported no permanent damage or scarring to the patient occurred due this event.No corrective action is necessary at this time.

Event Description

The patient applied heat or ice post procedure.Jewelry/body piercings were removed prior to treatment.The patient was alert and able to provide feedback throughout the treatment.The skin was flat during treatment and good skin contact was maintained throughout the treatment.

Manufacturer Narrative

The treatment tip has been requested for evaluation.Further investigation is pending.

Event Description

Clarification was received from the reporter that the atypical event experienced during the treatment was that "tip too warm" errors were recurring, even after replacement of the cryogen tank.This treatment was the initial use of the treatment tip.Four undated pictures of the patient's face were received.The first picture shows no event.The second picture shows blisters and erythema on the cheek and mandible.The next picture shows the lesions under medical treatment.The last picture shows minor erythema with blisters resolved and one hyperpigmented area visible.

• Brand Name: THERMAGE FLX (TG-3A) AND ACCESSORIES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18571104
• MDR Text Key: 333605915
• Report Number: 3011423170-2024-00116
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female