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

Model Number TT4.00F6-900

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

The first treatment tip was discarded and is not available for evaluation.Product evaluation was completed on the second treatment tip.Tip passed leak, visual, and thermistor testing.No functional testing was performed because the tip was expired.System data-log was reviewed, both the system and hand-piece performed as expected.A review of the device history record is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

It was reported by a physician's office that a patient experienced a burn following a thermage treatment.The patient was treated across the face and neck with a maximum power level of 7.The doctor reported that the patient was administered iv pain medication during the treatment.Following the procedure the patient returned home and then noticed that they had a second degree burn on both cheeks and neck.They visited a dermatology clinic and received an unknown treatment.The doctor indicated that cryogen coupling fluid was administered properly, and that the surfaces of both treatment tips were inspected prior to and during use with no observed abnormalities.After 325 pulses the first treatment tip was displaying an ec78c ''tip too warm'' error and was discarded for a second treatment tip.The treatment was completed with the second tip without any additional errors or issues.

Manufacturer Narrative

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.Data-logs confirmed the system and hand-piece perform as expected.Evaluation of the treatment tip found no issues.It was reported the patient was placed under sleep anesthesia.The patient should never be placed under anesthetics during thermage flx treatment.The customer 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.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 9603991
• MDR Text Key: 176767837
• Report Number: 3011423170-2020-00009
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR