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

Model Number TTNS3.00E4-900

Device Problems Pitted (1460); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

The device and data log of the event were returned and evaluated.The tip evaluation concluded the tip passed the flow test.However, the tip failed the leak test, thermistor test, and visual inspection.Burnt traces and dielectric breakdown were observed during visual inspection.No functional testing was possible due to the observation of burnt traces.A review of the manufacturing record is in progress but not yet complete.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that a patient experienced a burn on their forehead during a full face thermage treatment.The physician indicated that the maximum power level used was 3.5, that ample coupling fluid was used, and that the treatment tip was inspected before and every 50 shots during the treatment with no abnormal findings observed.It was noted that the system generated several error codes during the treatment, however the physician did not note which codes appeared.During the procedure the physician observed blisters forming on the forehead during the 6th pass over the area.Following the procedure the patient was treated with an unknown steroid ointment in the affected area.A post treatment photo was provided and reviewed, erythema and inflammation are visible on the forehead, the blisters are resolving.

Manufacturer Narrative

Corrected section g4.During evaluation of the treatment tip, service found a breakdown around the radio frequency trace of the tip membrane.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 breakdown of the dielectric membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the dielectric material, and/or build-up of foreign substance on the dielectric membrane, can cause the radio frequency 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 (p009240-05 rev.B) and technical bulletin tb-19 instructs the operator to inspect the treatment tips for any signs of physical damage.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 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 a dielectric breakdown, 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.Solta also reiterates the importance of clinician attention to treatment error messages provided by the system, in particular messages indicating under-force and lifting irregularities.As with all thermage systems, ensuring perpendicular contact between the handpiece and skin is critical.It was reported an unknown error occurred several times during treatment, but the physician didn''t check what error was displayed.Burns, blisters, scabbing, and scarring are all known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual (p009240-05 rev.B) 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.Evaluation of the treatment tip confirmed damage along the radio frequency trace of the tip.Investigation has found stress concentrations on the flex assembly, at the adhesive edge, cause damage to the radio frequency trace, leading to arcing and subsequent burn-through of the flex circuit membrane.Based on the available information, this event was most likely caused by damage on the treatment tip.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 12445706
• MDR Text Key: 270489263
• Report Number: 3011423170-2021-00098
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention