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

Model Number TTNS3.00E4-900

Device Problem Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 06/05/2022

Event Type  Injury  

Event Description

A distributor reported that a user facility performed a thermage treatment on a patient¿s face and the patient experienced burns on both cheeks.The patient was given topical anesthetics prior to the procedure.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 4.0.Treatment was delivered on the forehead for approximately 150 pulses and then the right side of the face for 375 pulses.The doctor heard some electric noise at the time and then erythema was observed on the patient¿s face after pulse delivery.The patient was immediately treated with burn ointment, a growth factor gel, and a cold compress.The treatment tip was inspected and it was noted the surface looked irregular.The tip was inspected prior to the procedure with no issues found.Available pictures were reviewed and immediately after the procedure, erythema, blisters and inflammation were visible.Three days after the procedure, erythema and inflammations are resolved.Crusts are scattered on both cheeks.The current status is reported as scabs with unknown outcome.The patient had not received any other treatment on the procedure day or within 30 days prior, in the same symptom area.

Manufacturer Narrative

The data log from the patient event was reviewed and based on available information the handpiece and system performed as expected.The treatment tip was returned to the manufacturer however evaluation has not yet begun.A plant evaluation has been initiated.

Manufacturer Narrative

The data log and treatment tip were returned for evaluation.The data log showed several errors had occurred during treatment.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency (rf) treatment, the rf 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 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 and leak testing however it failed thermistor testing and visual inspection.There was damage to the tip membrane in one corner where coupling fluid had ingressed.Tears or holes of the membrane can cause the rf 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 and could possibly cause patient burns.Ingress in coupling fluid can also impact thermistors causing reported errors.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.No corrective action required.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial/lot number.Based on the available information, the damage to the tip membrane most likely caused this event.Thermage user 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.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.According to thermage cpt system technical user¿s manual burns and redness are known possible patient reaction to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.

• 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: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 14951476
• MDR Text Key: 295475078
• Report Number: 3011423170-2022-00089
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 07/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female