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

Model Number TT4.00F6-900

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Scar Tissue (2060); Blister (4537)

Event Date 05/27/2023

Event Type  Injury  

Event Description

A distributor reported that a user facility was performing a thermage flx procedure to a patient''s face when skin blisters appeared during the treatment.During the treatment, the customer had experienced obvious pain.When the energy was reduced, the skin was normal.The energy range was at about 3.5-5.0 and adjusted accordingly for pain.At about 460 reps, obvious erythema could be seen in the lower area, and the left cheek treatment was continued immediately after an ice compress was applied.The energy range was 0.5-3.5, and the customer had obvious pain, so the energy was reduced to continue the operation.After 759 reps, blisters appeared on the lower part of the right cheek, so the treatment was stopped immediately, and obvious erythema also appeared on the left cheek.Immediately, an ice compress and scald cream were applied, but some redness and blisters still appeared on the cheeks of both sides of the face.The patient was instructed to continue the ice compress and scald cream and go to the hospital for a regular review.The exact location of injury includes the mouth angle, mandible and midface.The nature of the injury is reported as some redness and blisters.The patient was not administered any pain medication or placed under anesthesia.Secondary intervention (ointments, medications, etc.) required to treat this event includes an ice compress and scald cream.The patient''s current status and outcome is reported as post-inflammatory hyperpigmentation + a slight scar with hyperplasia.No photos are available as the customer declined to supply them.No other treatments (besides thermage) were being performed in same area where symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within the past 30 days.It is reported that there were error codes occurring during the treatment: four times the tip overheated and three times the tip supercooled.Solta medical croygen and coupling fluid were used during this treatment with enough coupling fluid to perform the treatment.The treatment tip surface was inspected prior to use, as well as during use (every 80-100 reps).There were no abnormalities reported.This is the first time the treatment tip was used.

Manufacturer Narrative

The datalogs were retrieved and reviewed.The data presents the following user errors: quantity - error id - description - percent of reps: 3 ec485 - err_treatment_tip_too_cold - 0.40%; 1 ec785 - err_treatment_tip_lifted_prematurely - 0.13%; 1 ec788 - err_treatment_tip_invalid - 0.13%; 4 ec78c - err_treatment_tip_temp_high - 0.53%.Based on the evaluation of the data, the system and the handpiece perform as expected.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Cryogen appeared to be flowing during the treatment.Based on the evaluation of the data, it is recommended to adhere to proper handpiece orientation, adequate coupling fluid being applied, and pressure.The tip was recently returned for an evaluation.A supplemental report will be filed as the investigation is underway.

Manufacturer Narrative

Evaluation of the system logs and treatment tip were completed.The datacard log confirmed the customer¿s account of "tip too warm" and "tip too cold" errors that occurred during the 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¿ or ¿tip too cold¿ errors and place the system into a safe state.This condition presented no patient risk.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.The review of the system/data logs did not indicate there was any handpiece or system issue present.When the system detects a condition that interrupts the 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.Cryogen appeared to be flowing during the treatment.Thermistor readings fluctuated during treatment indicating possible technique issues.The thermage flx tip was returned and evaluated by service.The tip was validated and verified against the solta database.The tip passed the leak test and thermistor tests.No functional test was able to be performed due to tip being expired.However, the tip failed visual inspection for a dent in the tip surface.Service was unable to determine when and how the dent happened.No dielectric breakdown was observed.It is unlikely that dents can contribute to the related complaint as it would not cause risk to the patient since the radiofrequency energy is still able to distribute across the tip membrane.According to the thermage flx user manual, blisters, redness, and discoloration 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.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, blisters, redness, and discoloration are known possible side effects during thermage flx treatment.No corrective action is necessary at this time.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17305442
• MDR Text Key: 318924347
• Report Number: 3011423170-2023-00065
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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