MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT4.00F6-900

Device Problem Excessive Heating (4030)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested and the investigation is underway.

Event Description

A user facility reported burns (2nd degree blisters) to the patient's left cheek during a thermage flx treatment to the face.The patient was treated with biomycin ointment.The current status was reported as blisters that are recovering with the possibility of a scar.Available pictures were reviewed by the medical reviewer and inflammation and erythema with minor blisters on lower left side of the face are visible.The patient was administered an iv superficial anesthetic for this procedure.It is reported that the blisters are resolving.No other treatments (besides thermage) were being performed in the same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The incident occurred at about 72 reps.The highest energy level used was tl 4.A "tip too warm" error occurred during treatment.The tip was switched to another one and no issues were reported.Solta medical cryogen and coupling fluid were used during this treatment.Approximately 40-60 ml of coupling fluid was used during the treatment.The treatment tip surface was inspected prior to use and nothing remarkable was anything noted.This is the first time the treatment tip was used.

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the handpiece and system performed as expected.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The tip was evaluated, and the tip failed the leak test.The tip also failed visual inspection for disturbed glue in one corner.No dielectric breakdown was observed.The datalogs also showed that the tip had an issue with the cryogen distribution.The thermistor 1 appeared warmer than the other thermistors; however, the tip passed the thermistor test.No functional testing was performed due to the tip being expired.It was reported that the patient was given iv superficial anesthetic for the treatment.The patient should never be placed under anesthetics during thermage flx treatment.The patient must be alert and provide required feedback during treatment.Patient feedback regarding their perception of heat or discomfort during the procedure is an essential input to guide the operator in determining safe and effective treatment levels.Based on the available information, this treatment was performed in an off-label manner that resulted in unsafe conditions for the patient.A review of the manufacturing records showed all requirements were met.The complaint type is identified within the risk analysis.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.No corrective action is required.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 15677104
• MDR Text Key: 302472412
• Report Number: 3011423170-2022-00138
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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
• Patient Outcome(s): Other