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

Model Number TTNS3.00E4-900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

A review of the system data-logs was completed.The log file indicated the system and handpiece used at the time of this adverse event performed as expected.The distributors engineer examined the treatment tip and indicated there was possible damage to the tip.Distributor indicated they retained the treatment tip for return.The tip has been requested for evaluation but not yet received by the complaint handling facility.A review of the device manufacturing record and trend/risk analysis have been initiated but not yet completed.Based on currently available information no findings are available and no conclusions can be drawn.

Event Description

A distributor reported that a patient experienced burn, blisters, and erythema on their forehead and left cheek following a thermage cpt facial treatment.The clinic reported completing this treatment using adequate coupling fluid at power levels 1.0 - 4.5.The tip was inspected prior to use, as well as about every 80 pulses during use, with no observed abnormalities noted.Prior to treatment the patient was administered topical anesthetics and oral ibuprofen prior to undergoing treatment.At about 850 pulses the clinician noted small white blisters appearing on the forehead and reduced the treatment power level to 1.The treatment was then completed.Following treatment the clinician noted that there were blisters on the forehead and the left cheek was red and swollen.The patient was treated with hydropathic compress with ns+ dexamethasone, and growth factor gel.The following day it was reported the patient reaction on the forehead was recovered however the left cheek reaction remained aggravated with linear erythema and scabbing noted.Available pictures were reviewed.Scabs are visible on the patient left cheek along with redness.The current status reported as scabs with unknown outcome.

Manufacturer Narrative

The treatment tip was returned and the evaluation was completed.During evaluation of the treatment tip, service found a dielectric breakdown around the radio frequency trace.The investigation found that trace damage from the tip membrane are caused by stress concentrations on the flex assembly at the adhesive edge that damaged the radio frequency trace, causing arcing and subsequent burn-through of the flex circuit membrane.This burn through can cause risk to the patient during treatment.The tip passed the flow test, leak test, and thermistor test.The tip failed the visual inspection as dielectric breakdown was observed.No functional testing was performed due to the dielectric breakdown.A review of manufacturing records showed all requirements were met.The final test verification specifications are acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.The root cause was determined to be a component issue.There is currently a corrective action in place for further investigation of the issue.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n, unit 400; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 14090169
• MDR Text Key: 294521937
• Report Number: 3011423170-2022-00040
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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
• Treatment: UNKNOWN TOPICAL ANESTHETIC AND ORAL TYLENOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female