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

Model Number TTNS3.00C1-200

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Data log review of the event was completed.Data log review showed hand piece and system performed as expected.Treatment tip has been requested for return but not yet received for evaluation.A review of the device manufacturing record is in progress but not yet complete.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A clinic reported that a patient experienced a burn during their thermage procedure.The nurse reported that frost was observed on the patient¿s lower left face just after the area was treated.A burn mark was also visible in the same area of the face.The available image was reviewed and two red lines are visible on the left cheek.The patient was treated with an unknown healing serum and intense pulsed light therapy.The patient''s current status was reported as the redness has subsided and residual hypopigmentation in the burn area is still visible.The treatment was performed at a maximum power level of 3.5.The treatment tip was inspected prior to use and no abnormalities were noted.Following the observation of frost on the patient the treatment tip was swapped out, but the system would not allow additional shots to be administered so the treatment was not completed.

Manufacturer Narrative

The treatment tip has been returned and evaluated.Tip passed flow, leak, and thermistor testing.Tip passed visual inspection; no dents, scratches, blemishes, or dielectric breakdown was observed.Functional testing was performed with no errors or other issues observed.A review of the device manufacturing record is in progress but not yet complete.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

Corrected section d7a.A review of the manufacturing records show all requirements were met.The treatment tip and data-card logs were returned for evaluation.Evaluation of the treatment tip found no issues related to this event.Evaluation of the data-card found no issues with the system and handpiece, they performed as expected.Data-card logs do however show a large number of user errors, where constant force or full contact with skin was not maintained during the treatment.Failure to maintain constant force until the tone ends, indicating the end of the post cooling state, can result in an unsafe condition.If full perpendicular contact is not made during treatment, cryogen can pool to one side of the tip creating frosting on the tip surface, as was reported in this case.It was also reported this tip was used on a prior treatment.Thermage treatment tips are single use only, as re-use can lead to unsafe risks to patients.Based on the available information user technique and off-label use of the treatment tip resulted in unsafe treating conditions, most likely causing this event.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; 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: 12521441
• MDR Text Key: 273768645
• Report Number: 3011423170-2021-00107
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2021

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: TTNS3.00C1-200
• Device Catalogue Number: TTNS3.00C1-200
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 09/30/2021; 11/14/2021
• Supplement Dates FDA Received: 10/29/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female