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

Model Number TTNS3.00E4-900

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

The treatment tip datalogs have been evaluated.Multiple error messages were received during the treatment, including overforce and underforce errors, button released early, temperature limit exceeded, and force too high when button pushed.The treatment tip was evaluated, and the tip failed the flow test but passed the leak test.The tip failed visual inspection due to a point in the center of the tip, a dent in the tip surface, and a damaged corner.No dielectric breakdown was observed.The tip passed the thermistor testing.Functional testing could not be performed due to the tip being used up and expired.Further investigation is underway.

Event Description

A user facility reported that a patient was burned on the face (on the cheek and base of the nose) during a thermage cpt treatment.On the left face and mandible and right mandible there immediately appeared more punctuated red rashes.Anesthetic was applied to the face for 30 minutes before the treatment.The treatment started with the forehead (about 90 reps), then the right face and jaw (about 300 reps at energy range 2.0-3.0), and finally the left face and jaw.The customer experience was normal until 170 reps remained on the left side of the face.The patient experienced a strong pain, and the skin had a white spot reaction when the outer mouth corner was treated with 2.5 energy level.The treatment tip was then checked, with no anomaly noted.The doctor replaced the loop patch and applied more coupling agent and reduced the energy to 0.5-1.0.The patient still had a tingling sensation at this energy level but said it was tolerable, but he felt like the current was passing through.A different provider took over the treatment with an energy level of 2.0.During this period, error e138 (maximum temperature exceeded) was received, and the customer reported feeling a current passing through each rep.The doctor also reported that there was an abnormal noise during the rf energy emission.The patient insisted on finishing the treatment.After the treatment, the left side of the face and mandible and right mandible showed punctuated red rashes.The patient was treated with an emulsion mixed with youzhuoer ointment, the face was iced for 20 minutes, and loratadine tablets were taken.When the patient left the hospital, the rash disappeared and he was told to go home and continue to apply the ointment.No other treatments were being performed in the same area where symptoms were observed, nor had other treatments been performed in the previous 90 days.The energy of the first 700 reps was 2.0-3.0 and the energy of the last 170 reps was 0.5-2.0.Solta medical cryogen and sufficient coupling fluid was used during the treatment.This treatment was the initial use of the treatment tip.It was inspected prior to use and when the scalding occurred with no anomalies observed.It has been noted that the doctor initially performing this treatment is not certified.The patient has not fully recovered.The rash has partially subsided.It is unclear if there will be permanent damage or scarring.

Manufacturer Narrative

Evaluation of the datacard logs showed the following errors occurred during treatment: quantity - error id - description - percent of reps 10 - 128 - overforce during rf on - 1.11% ; 3 - 131 - underforce during rf on - 0.33%; 4 - 132 - underforce during post cool - 0.44%; 1 - 133 - underforce during rewarm - 0.11%; 3 - 135 - hp button released during rf - 0.33%; 2 - 136 - hp button released during post-cool - 0.22% ; 15 - 138 - temperature limit exceeded - 1.67%; 10 - 211 - force too high when button pushed - 1.11%.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 there is any handpiece or system issue present.The datacard log confirmed the customer¿s account of tip too warm error (e138) 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.During evaluation of the treatment tip, service found a dent and tear in the tip membrane.There is no risk to patient to due to the dent.The tear observed in 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 and could possibly cause risk to patient.The thermage user manual 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.According to thermage cpt system technical user¿s manual redness is a known possible patient reaction to thermage treatment.Erythema / blanching may occur in mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer (up to several weeks).Blanching usually resolves within twenty-four (24) hours.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities 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.During evaluation of the treatment tip, service found a tear on the tip membrane.Based on the available information, the tear to the tip membrane most likely caused this event.It is unknown what caused the damage to the tip.All treatment tips are visually inspected for any damage or defects during manufacturing and packaging.This damage could occur during handling of the tip.No corrective action is necessary at this time.

Manufacturer Narrative

This event no longer meets reportability requirements as no serious injury occurred.The conclusions of the previous report remain unchanged.

Event Description

The reporter stated that the consumer has recovered without scars.Patient pictures were provided.The solta medical reviewer reassessed the case with the new information.The three undated pictures were reviewed.One picture shows erythema and inflammation on one side of the face around the cheek to neck area.The second picture shows small crusts scattered around the same areas of the face.The third picture (other side of the face) shows small crusts on the neck.Based on the new information, the solta medical reviewer concluded that this event is not a serious injury.The event no longer meets reportability requirements.

• 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: 18235618
• MDR Text Key: 329314686
• Report Number: 3011423170-2023-00102
• Device Sequence Number: 1
• Product Code: GEI
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• 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
• Patient Sex: Male