MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE CPT SYSTEM TIP; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Itching Sensation (1943); Anxiety (2328); Discomfort (2330); Skin Burning Sensation (4540); Swelling/ Edema (4577); Hyperpigmentation (4837)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip was returned and evaluated.The tip had been used for 702 treatments.The tip passed the flow, leak and thermistor test.The tip failed visual inspection due to the observance of dielectric breakdown; as such, functional testing was unable to be performed.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of first and second-degree patient burns associated with dielectric membrane the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area.Both the thermage user manual and technical bulletin tb-19 instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after treatment.With respect to all thermage systems, clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during the treatment.In the case of damage to the membrane, the clinician may notice the onset of small burns which would be evidenced by small residual focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Burns are known possible adverse patient reactions to thermage cpt treatment.Thermage system technical user¿s manual states the procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of a topical steroidal or antibiotic preparation may be of benefit.No non-conformities 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 were considered acceptable, with the product performing within anticipated rates based on the available information, this event was most likely caused by dielectric membrane to the tip.It is unknown how damage to the treatment tip occurred as all treatment tips are visually inspected during manufacturing.At this time, no capa is necessary.
Event or Problem Description
It was reported that a patient experienced a burn during a thermage cpt full-face treatment.The patient was burned on both sides of the lower face and experienced itch and pain.The patient¿s face became red and hot.The patient had not been administered any pain medicine or placed under anesthesia prior to the treatment.The treatment tip was observed to have a hole in it mid-treatment.The highest energy level used was 8.Upon return of the treatment tip for evaluation, dielectric breakdown was observed.This event meets the definition of a reportable malfunction per solta procedure.
Event or Problem Description
Additional information was provided by the user facility.The patient's previous problem caused some areas on her face to become red, swollen and itchy.After the redness and swelling subsided, hyperpigmentation began to appear.This made the client feel very anxious and not wanting to go out to meet people for a few days.The patient was given treatments such as: picoway, vbeam, and facial to ensure that her face recovers.The patient's current status was described as better than before, but there were still traces of pigmentation when looking carefully.The skin epidermis was damaged and left with pigmentation.The patient will be given 10 sessions of ultra-picosecond plus sakura laser to repair the pigmentation.She has done two of these treatments so far and there has been a definite improvement in pigmentation.No photographs were available as the guests do not allow it.No eye shield was used.No other treatments (besides the one reported) were being performed in same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days, nor has the patient ever had prior aesthetic treatments on this area.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Both a stamping and sliding method were used.Solta cryogen and 1-2 bottles of unscented coupling fluid were used.The treatment tip surface was inspected prior to use and at about every 300-400 pulses and had not been used on any other patients.
Additional Manufacturer Narrative
The conclusions from the previous report submission remain unchanged.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Common Device Name: 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 north 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: 19376487
• Report Number: 3011423170-2024-00161
• Device Sequence Number: 7703407
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown