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

Model Number TTNS3.00E4-1200

Device Problem Material Discolored (1170)

Patient Problems Erythema (1840); Blister (4537)

Event Date 09/30/2022

Event Type  Injury  

Event Description

A user facility reported that a black dot, at pulse 1030, suddenly appeared during a thermage face treatment.The technician stopped using the tip right away.There was redness with blister like white bubbles on the patient's right side of the face.No treatment was provided.The current status was reported as redness with a feeling of hotness on the right side of the face.The outcome is unclear at this time.Three pictures were available and reviewed by the medical reviewer.No timeline or dates were given for the pictures.Small crusts and tiny hyperpigmented areas were visible on one side of the face.Since the timing of the pictures were not reported, it is hard to evaluate the recovery process.The patient was not administered any pain medication or placed under anesthesia.No secondary intervention (ointments, medications, etc.) were required to treat this event.It is unclear if there will be any permanent damage or scarring.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used was 3.5.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta medical cryogen and coupling fluid used during this treatment - approximately 4 bottles.The treatment tip surface was inspected prior to use and nothing remarkable was noted.The treatment tip surface was re-inspected the during the treatment at about every 10-15 pulses.This is the first time this individual treatment tip was used.

Manufacturer Narrative

The product has been requested and the investigation is underway.

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the handpiece and the system performed as expected.There seemed to be some over force treatments during the treatment.The error indicates a recoverable problem that requires operator intervention.If the error occurs during a radiofrequency treatment, the radiofrequency 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.The treatment tip was returned and evaluated.The tip was used for 1030 treatments.The tip passed the flow, the thermistor, and leak tests.The tip failed visual inspection for dents in the tip surface.Service was unable to determine when and how the dent happened as all treatment tips are visually inspected during manufacturing.The tip also failed visual inspection for a burn mark on the tip surface as dielectric breakdown was present.Functional testing was not performed due to the burn mark on the tip surface.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of potential risk to patients associated with dielectric membrane breakdown of 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 a technical bulletin 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 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 and blisters are all known possible adverse patient reactions to the thermage 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 topical steroidal or antibiotic preparations may be of benefit.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, this event was most likely caused by the breakdown to the tip membrane.It is unknown how the damage to the treatment tip occurred.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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: 15684123
• MDR Text Key: 302573830
• Report Number: 3011423170-2022-00139
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• 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