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

Model Number TTNS3.00E4-1200

Device Problems Hole In Material (1293); Material Puncture/Hole (1504)

Patient Problem Inflammation (1932)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation complete: p/n#ttns3.00e4-1200; lot#092017; (b)(4).On (b)(6) 18 at 11:48:55 am the tip was used for 1200 treatments.The tip passed flow test, leak test, and thermistor testing.The tip failed visual testing due to dielectric breakdown being present.Functional test was not performed due to e234 (zero reps remaining).The evaluation of the system treatment log found a warning error: failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition.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 review of the system/data logs does not indicate there is any handpiece or system issue present.Further investigation is underway.

Event Description

The user facility reported a patient underwent thermage treatment on left side of face, forehead and cheek.The highest energy level used: 2.5.The lowest 1.5.Blisters were not visible during treatment; however when the thermage handpiece vibration stopped they noticed blisters on the forehead and cheek.The blisters were small and superficial in nature and there was no redness.Prior to treatment oral medication was given, no topical medications were used.When the patient returned the superficial water blisters were already healing and otc aquaphor was recommended.No medical/medication intervention was required.

Manufacturer Narrative

During evaluation of the treatment tip, service found a dielectric breakdown to the tip membrane.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 dielectric 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 (p009240-04 rev.A) and technical bulletin tb-19 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.Solta also reiterates the importance of clinician attention to treatment error messages provided by the system, in particular messages indicating underforce and lifting irregularities.As with all thermage systems, ensuring perpendicular contact between the handpiece and skin is critical.Burns, blisters, scabbing, and scarring are all known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual (p009240-04 rev.A) 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.Based on the available information, dielectric breakdown of the tip most likely contributed to this event.When the patient returned to the clinic, the superficial water blisters were already healing and otc aquaphor was recommended.No medical/medication intervention was needed.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

• Brand Name: THERMAGE TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; bothell WA 98011
• MDR Report Key: 7620689
• MDR Text Key: 112229984
• Report Number: 3011423170-2018-00058
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1