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

Model Number TTNS0.25NB1-450

Device Problem Temperature Problem (3022)

Patient Problems Skin Discoloration (2074); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 05/10/2022

Event Type  Injury  

Event Description

A distributor reported that a user facility had performed a thermage treatment on a patient.The patient experienced blisters on both eyelids and hyperpigmentation on the second day.The patient was given topical anesthetics, epihemp compound lidocaine.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 4.0.Treatment to the patient¿s eyelids was started and on the 5th pulse delivery, an event code occurred indicating the tip may be too cold.The tip was removed and reinstalled until the event code went away.The event code returned again however the treatment was not stopped and following completion of the eyelids, it was noted the patient¿s eyelids looked white so they were immediately given burn ointment.The treatment tip was inspected prior to the procedure and during every 50-80 pulses with no discrepancies observed.Pictures of the patient were reviewed and post inflammatory hyperpigmentation was visible on one eye lid but no injury was seen on the other.The patient had not received any other treatment on the procedure day or within 30 days prior in the same symptom area.The current status is reported as blisters recovered with scabs.

Manufacturer Narrative

The data logs and treatment tip from the event have been requested to be returned for evaluation but have not yet arrived.A plant evaluation has been initiated.

Manufacturer Narrative

The data log and treatment tip were returned for evaluation.The data log showed many user related 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 "action required" mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on available information, the handpiece and system performed as expected.The reported temperature event code was likely due to the user tilting the handpiece causing uneven cryogen delivery to the patient.The treatment tip passed flow, leak and, thermistor testing however it failed visual inspection.A dent was found on the tip membrane but it''s unlikely this contributed to the patient injury.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 were 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, no causal factors can be determined and no conclusion can be drawn.According to thermage cpt system technical user¿s manual, burns and blisters, are known possible patient reaction to thermage cpt 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: 14848181
• MDR Text Key: 295118670
• Report Number: 3011423170-2022-00084
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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 Age: 27 YR
• Patient Sex: Female