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

Model Number TTNS3.00E4-1200

Device Problem Material Puncture/Hole (1504)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

A user facility in canada reported an adverse patient reaction during a thermage cpt treatment.At the end of the facial treatment, white bumps and redness were observed on the side of the face treated in the second half of the procedure.The reporter indicated that the patient had burns on the right side of the cheek and the jawline.No burn treatment was reported.It is unclear if there will be permanent damage.No event codes or system errors occurred during the procedure.The highest energy level used was 3.5.Cryogen and coupling fluid were used during the treatment.The treatment tip was inspected prior to the treatment (which was the initial use of the tip) but was not reinspected during the treatment.The reporter indicated that the tip is available for return.The reporter noticed a small piercing in the center of the tip.The medical reviewer reviewed the case file and available picture.The exact location of the burn was noted to be the right side of the cheek and the jaw line.Review of the picture shows erythema and inflammation are visible on one side of the face and neck area.Blisters are visible on the neck.

Manufacturer Narrative

It was reported that the tip used on this treatment appears to have a small piercing in the center of the tip.The treatment tip has not been returned for evaluation.The datacard logs from the system were returned for evaluation.Service could not find logs corresponding to the reported treatment time.Based on the evaluation of data the system and the handpiece performed as expected.According to thermage system technical user¿s manual burns and blisters are known possible adverse patient reactions to thermage 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.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 directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factor can be determined, and no conclusions can be drawn.Trending will be performed to monitor this issue.Should the treatment tip be returned for evaluation, the investigation will be updated.No corrective action is necessary at this time.

Manufacturer Narrative

The treatment tip was returned for evaluation.The evaluation confirmed a burn mark on the surface of the tip as well as dielectric breakdown of the tip membrane.A dent was also observed.The tip passed flow, leak, and thermistor testing.Functional testing was unable to be performed due to the burn mark and due to all of the tip¿s reps having been spent.Evaluation of system logs has been completed.The thermage 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.Breakdown of the dielectric material, and/or build-up of foreign substance on the dielectric, 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.Rf trace on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.A dent on the tip was also observed during evaluation but this would not cause the reported event service confirmed damage to the tip membrane along the rf trace.Based on the available information, this event was most likely caused by damage on the tip membrane.All tips are visually inspected for damage during manufacturing.A corrective action is in the process of being implemented in order to reduce recurrence rates.Traces are strained at outer radius of the tips during use.The staining causes friction between the raw copper and the plastic insert.This can lead to the copper fatiguing over time, causing cracks.A protective back layer is under development that will be placed on the backside of the flex, providing additional mitigation against a conductive leak path.

Event Description

A patient update provided by the reporter indicated that there will likely not be permanent scarring, but that the patient still has some discoloration.The user facility has provided a serum and plans to do a facial peel later in the year when there is less sun.An updated patient picture was provided, which was reviewed by the solta medical reviewer.The picture shows some discoloration (hyperpigmentation) on one side of the cheek.No other injury is visible.The event is reassessed as not serious, however, the dielectric breakdown observed during the product evaluation meets reportability requirement as a reportable malfunction.

Manufacturer Narrative

Based on the new information, this event was not a serious injury.The event remains a reportable malfunction due the ability of the dielectric breakdown of the tip membrane to cause patient adverse event.The conclusions from our previous submission remain unchanged.

• 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: 17143634
• MDR Text Key: 317449166
• Report Number: 3011423170-2023-00062
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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