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

Model Number TTNS3.00E4-1200

Device Problem Material Deformation (2976)

Patient Problems Erythema (1840); Blister (4537)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

The data logs and treatment tip were returned for evaluation.The data log showed a temperature related error had occurred during the event.Errors indicate a recoverable problem that require operator intervention.If the error occurs during a radio-frequency treatment, the radio-frequency delivery will be stopped, and 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 an "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 and system performed as expected.The treatment tip passed flow, leak, and thermistor testing, however failed visual inspection.A black mark was observed on the tip membrane and dielectric breakdown was present.No further functional testing could be performed on the tip due to the black mark on the 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 dielectric membrane the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the 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 and technical bulletin instruct 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 a damage to 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.Blisters are known possible adverse patient reactions to thermage cpt 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.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial number.Based on the available information, this event was most likely caused by damage to the tip.It is unknown how damage to the treatment tip occurred.All treatment tips are visually inspected during manufacturing prior to shipment.No corrective action is necessary at this time.

Event Description

A user facility reported that a patient experienced blisters and scabs on the right side of their face following a thermage cpt treatment.Solta medical branded cryogen and 3.5-4 bottles of coupling fluid was used with the highest level of treatment at 4.0.After 1,055 pulses were delivered, the provider observed a black spot was present on the tip membrane.The provider reported no system errors had occurred during the treatment.This was the first time the treatment tip was used on a patient and the provider checked the tip prior to use and every 5-10 pulses during the procedure.After the treatment, the patient went home and found blisters and scabs had developed on the right side of their face.The patient did not receive any other procedures in the symptom area on that day or within 30 days prior.The patient outcome is unknown.A solta medical reviewer examined patient photos and observed erythema and scabs were visible on one side of the patient¿s face.It was determined there were a limited number of small scabs that would not likely lead to a permanent scar, therefore it was deemed no serious injury had occurred.Solta service depot evaluated the returned tip and confirmed there was a black spot on the membrane and also found dielectric breakdown.This dielectric breakdown damage can lead to a serious injury if it were to reoccur and is the reason for this report.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north 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; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17799820
• MDR Text Key: 324054196
• Report Number: 3011423170-2023-00083
• 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,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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