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

Model Number TTNS3.00E4-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested and the investigation is ongoing.

Event Description

A distributor reported that a patient''s left and right cheeks on the face turned red with blisters from a cpt thermage treatment.The physician gave the patient an ice compress.The next day, the patient went to the local hospital for treatment and was diagnosed with second-degree burns and was also given a prescription.At present, the blisters are scabby.

Event Description

Additional information was received and reviewed.Pictures of the patient reveal that blisters are visible on both cheeks.The patient was administered topical anesthetics for 30-40 min.Secondary intervention (ointments, medications, etc.) was required to treat this event - ice immediately and then erythromycin.No other treatments (besides thermage) being performed in same area where symptoms were reported; nor has the patient undergone any other treatments in the same symptom area within the past 30 days.The incident occurred at about 900 reps.The highest energy level used was 1.5¿4.5.Solta medical croygen and coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and nothing remarkable to report.The treatment tip surface was not inspected during the treatment.

Manufacturer Narrative

The treatment tip and datacard log were returned for evaluation.The datacard log showed that an error occurred during 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.Based on the evaluation of the data, the handpiece did not perform as expected.No handpiece was returned for evaluation.During evaluation of the tip, service confirmed damage to the tip membrane along the radio frequency trace.The investigation found that stress concentrations on the flex assembly at the adhesive edge that damaged the radiofrequency trace, causes arcing and subsequent burn-through of the flex circuit membrane.Breakdown of the dielectric material, and/or build-up of foreign substance on the dielectric, 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.The tip passed the flow test, leak test, and thermistor test.The tip failed the visual inspection as dielectric breakdown was observed.No functional testing was performed due to the dielectric breakdown.Thermage cpt system technical user¿s 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.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, blisters are a known possible reaction to treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.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.Based on the available information, this event was most likely caused by damage on the tip membrane.There is currently a corrective action in place for this issue.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 15643199
• MDR Text Key: 302164486
• Report Number: 3011423170-2022-00131
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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?: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• 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
• Patient Sex: Female