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

Model Number TTNS3.00E4-900

Device Problem Material Discolored (1170)

Patient Problem Blister (4537)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

A user facility reported to the distributor that a while a doctor was treating a patient with a theramge cpt treatment, a patient experienced pain.The doctor saw that there were black spots on the kapton.He immediately stopped the treatment and gave the patient an ice compress.After a few minutes, the middle part of the right cheek became red and swollen.After 20 minutes of ice compress, scattered blisters appeared on the right cheek and forehead.Growth factors were applied, the current status of the patient is noted as the scab falling off without permanent scarring.The medical reviewer assessed this case as not serious.The tip was returned and evaluated, and dielectic breakdown was observed.

Manufacturer Narrative

The data logs were reviewed by service and the system and handpiece performed as expected.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The tip was returned and evaluated.The tip passed the flow, leak, and thermistor tests.The tip failed visual inspection due to a burn on the tip surface - dielectric breakdown was observed.Functional testing was unable to be performed due to dielectric breakdown the on the tip surface.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of first- and second-degree patient burns associated with breakdown of the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the membrane can cause the radiofrequency 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.Both the thermage user manual and technical bulletin 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.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of a damage to membrane, the clinician may notice the onset of small burns which would be evidenced by small residual focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Burns, blisters, scabbing, and scarring are all known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual states the procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.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.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.Based on the available information, damage to the tip membrane of the tip most likely contributed to this event.It is unknown how the damage to the tip membrane occurred.All thermage tips are inspected for defects before shipment to customers.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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: 16188785
• MDR Text Key: 308827743
• Report Number: 3011423170-2023-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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