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

Model Number TT4.00F6-900

Device Problems Insufficient Cooling (1130); Infusion or Flow Problem (2964)

Patient Problem Blister (4537)

Event Date 04/21/2023

Event Type  Injury  

Event Description

A user facility reported a blister to the patient''s chin 1 day after a thermage flx treatment to the face and neck.It is reported that a patient noticed a blister 1 day post treatment and did not call the user facility.The patient did home wound care when the blister was noticed.The patient reported the blister to the physician 3 days post treatment while she was being seen for unrelated care and mentioned it to the doctor.Clinically, the injury is described as a 4 mm superficial erosion without any evidence of infection.The facility reports that just after treatment there was a 3-4 mm white area with 2 mm surrounding pink.The exact location of injury is reported to be the right submentum.For this procedure, the patient was given pronox (nitrous + o2 mixed 50/50), gently.This was voluntary and patient controlled with the patient awake & conversing.Secondary intervention (ointments, medications, etc.) consisted of stratamed twice a day for 1-2 weeks.It is uncertain if there will be any permanent damage or scarring.Available pictures were received and reviewed by the medical reviewer.A lesion is visible on the submentum area close to the neck.It is unclear if the lesion is a blister since the picture is blurry.On the second picture no apparent lesion is visible.No other treatments (besides the one reported) were being performed in same area where symptoms were reported.The patient had kybella in the region a month prior, but it is unclear if it was in the same exact spot.The highest energy level used was 2.0.A few tip too warm errors occurred while treating the face.In subsequent treatments, the reporter noticed that she did not hear or see cryogen during treatments.Solta medical cryogen and coupling fluid were used during this treatment.The treatment tip was inspected prior to use and there was nothing remarkable.The treatment tip surface was re-inspected regularly during the treatment.This is the first time this tip has been used.

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the system performed as expected.However, the handpiece did not perform as expected.Cryogen is not flowing through the handpiece to the treatment tip.If cryogen is not flowing through the handpiece, the temperature monitor will catch this condition and display a ¿tip too warm¿ error and place the system into a safe state.The data also showed tip too warm errors, force before activation errors, and tip lifted prematurely errors.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 datacard log confirmed the customer¿s account of tip too warm error 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¿ error and place the system into a safe state.This condition presents no patient risk.According to thermage flx user manual, burns and blisters 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.No treatment tip or handpiece were evaluated at the time of this investigation.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is necessary at this time.The complaint type is identified within the risk analysis and performing within the anticipated rate.Solta medical is making attempts to retrieve the tip for evaluation.Should the tip be returned, a supplemental report will be filed.

Manufacturer Narrative

The thermage flx tip was returned and evaluated.The tip passed the leak test and visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.The tip also passed the thermistor test.No functional test was able to be performed due to tip being expired.The datacard log confirmed the customer¿s account of tip too warm error occurring during treatment.Based on the evaluation of the data, the system performed as expected, however, it appears that cryogen was not flowing through the handpiece to the treatment tip.The reported tip too warm error could have been caused by the handpiece.If cryogen is not following through the handpiece the temperature monitor will catch this condition and display a tip too warm error and place the system into a safe state.This condition presents no patient risk and thus is unrelated to the adverse event.An evaluation of the handpiece showed that the lee valve was plugged.The lee valve and inline filter were replaced.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information the root cause of this event is the fact that burns and blisters are a known possible side effect during a thermage flx treatment.No corrective action is necessary at this time.

Event Description

The patient is still using biocorneum and is having a small amount of thickening or scarring to the area at this time.The patient will be treated for the scar with the fraxel laser.

• 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: 16963046
• MDR Text Key: 315588749
• Report Number: 3011423170-2023-00051
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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