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

Model Number TTNS0.25NB1-450

Device Problems Pitted (1460); Material Puncture/Hole (1504)

Patient Problem Burn(s) (1757)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the handpiece and system performed as expected.The tip has been returned and will be evaluated shortly.

Event Description

A user facility reported that a patient received a thermage treatment on the left eye and the patient smelled something burning.The system showed an error message and the doctor changed the return pad and continued the treatment.The error occurred more than 10 times, to which the patient then refused treatment.The patient cleaned her eyelids and found damage on her lower eyelids.The doctor inspected the tip and found there was a hole on the surface of the thermage treatment tip.The patient was given mupirocin ointment and growth factor to use daily.Available pictures were reviewed.Scabs are visible around one eye in the first picture.In two other pictures, the scabs are recovered with some visible post inflammation hyperpigmented area.It is noted that topical anesthetics were used for this procedure.The patient's current status is noted as an atrophic scar.It is uncertain if there will be permanent damage or scarring.No other treatments (besides thermage) were being performed in same area where the symptoms were reported.The patient hasn't undergone any other treatments in the same symptom area within the past 30 days.It is reported that the incident occurred at about 285 reps into the procedure.The highest energy level used was 5.0.Solta medical croygen and coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use.Nothing was noted out of the ordinary and this is the first time the tip was used.The tip wasn't inspected during use and it was the first time it was used.

Manufacturer Narrative

Correction: medical device problem code from 1460 (pitted) to 1504 (hole).The thermage tip was returned and evaluated.The tip passed the flow and thermistor test.The tip failed the leak test.Visual inspection revealed dielectric breakdown.No functional testing was able to be performed due to the burnt mark on tip.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.The review of the system/data logs does not indicate there is any handpiece or system issue present.The plant evaluation is underway.

Manufacturer Narrative

During evaluation of the tip, service confirmed dielectric membrane breakdown on the tip.Breakdown of the dielectric material 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.All the tips are visually inspected during the manufacturing and packaging process for any signs of damage to the tip membrane.According to thermage cpt system technical user¿s manual, burns are a known potential reaction to treatment.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.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.Datacard logs revealed errors occurred during treatment.Errors indicate 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 data, the system and handpiece performed as expected.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.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, damage to the tip caused this event.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 north creek pkwy; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 13891857
• MDR Text Key: 287839419
• Report Number: 3011423170-2022-00029
• 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: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS0.25NB1-450
• Device Catalogue Number: TTNS0.25NB1-450
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Sex: Female