MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE CPT SYSTEM AND ACCESSORIES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI

Model Number TTNS3.00E4-1200

Device Problem Break (1069)

Patient Problems Burn(s) (1757); Swelling/ Edema (4577)

Event Date 12/23/2023

Event Type  Injury  

Event Description

It was reported that a patient experienced burns on the face during a thermage cpt facial treatment.Scattered punctuated and multiple linear epidermal damage with mild swelling was found in the left, middle, and lower face and submaxillary.The patient was administered topical anesthesia prior to treatment.The physician noted that during the treatment, the patient did not feel the pain increasing, but felt slightly weaker than the pain in the right face.During the treatment, the patient felt a slight tingling sensation, which was obvious on the treated side.The patient had complained of the smell of burnt hair during the treatment but was not bothered.The treatment consisted of 1200 reps.When 61 reps were left, multiple scattered punctuated epidermal lesions and mild swelling were found on the left middle and lower face and under the jaw.Damage to the electrode line at the edge of the dielectric film of the treatment tip was detected.The edge of the dielectric film was reportedly damaged linearly (the first line perpendicular to the electrode line, about 3mm long).Pictures of the patient or treatment tip were not provided to solta for review.No other treatments (besides thermage) had been performed in the same treatment area within the last 30 days.The incident occurred at approximately 100 reps.The highest energy level used was 2-5.5.Solta medical cryogen and sufficient coupling fluid were used during the treatment.The treatment tip was not inspected prior to use but was inspected every 100 reps during the treatment.Secondary intervention was described as follows: preliminary treatment: in-hospital treatment including cleaning the skin with physiological saline and applying growth factor gel externally and applying ice pack for half an hour, following with 820nm laser inject for 20 minutes.Care after returning home: (left cheek, mandible): patient was advised within 72 hours to avoid water, apply local ice, and avoid strenuous exercise.External medical mask (1-2 times/day) - external spray acidic growth factor spray (2 times/day) - growth factor gel (2 times/day) - elosone ointment (1 time/day); after 72 hours patient was recommended to wash face with water - external medical mask - external spray of acidic growth factor spray - growth factor gel/collagen dressing - lotion, no makeup, makeup remover, facial cleanser; scabs will fall off after 3-7 days, normal washing and makeup can be done; strict sun protection for at least 1-day months: physical sun protection: hat, mask, glasses; chemical sun protection: sunscreen (after 7 days).The patient¿s current status was described as local skin damage and scabs, noting there is no serious sequela.The facial scabbing has not completely fallen off.The patient is being closely followed up for possible hyperpigmentation.

Manufacturer Narrative

The investigation is underway.

Manufacturer Narrative

Though requested, the treatment tip was not returned and datalogs have not been provided for evaluation.A review of the manufacturing records showed that all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies were found related to this event 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 the thermage cpt user manual, burns and swelling are a known possible reaction to 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.The reported tip membrane damage could not be confirmed as the product was not returned.Based on the available information, no causal factors can be determined and no conclusions can be found.No corrective action is necessary at this time.

Manufacturer Narrative

The datalogs have been returned for evaluation.The following error messages were observed: quantity - error id - description - percent of reps (b)(4) - force too high when button pushed - 0.97% (b)(4) - hp button released during rf - 0.35% (b)(4)- one half tip rep remaining - 0.09% (b)(4) - tm1 disconnected - 0.09% 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.Error indicates a recoverable problem that requires operator intervention.If the error occurs during an rf treatment, the rf delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip was returned and inspected.The tip passed the flow, test, and thermistor testing.Functional testing (50 treatments) was performed with no errors or other issues observed.The tip passed visual inspection, as no dents, scratches, blemishes, or dielectric breakdown was observed.In conclusion, service could not confirm damage to the tip membrane as reported.Evaluation of the treatment tip found no issues with the tip.Datacard logs showed the handpiece and system performed as expected.Based on the available information, burns and swelling are a known possible reaction to treatment.

Event Description

The patient has received intense pulsed light (ipl) therapy on the affected areas two months ago.No dissatisfaction was reported from the patient after the ipl procedure.The assessment remains as a serious injury due to a treatment that is considered beyond the standard of care.

• Brand Name: THERMAGE CPT SYSTEM 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: 18924476
• MDR Text Key: 337911390
• Report Number: 3011423170-2024-00132
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female