MAUDE Adverse Event Report: Avanos Medical Inc. COOLIEF Cooled RF Advanced Generator; Generator, Lesion, Radiofrequency

Model Number	CRG-ADVANCED
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cervical radiofrequency ablation (rfa) procedure, a patient with a pacemaker/implantable cardioverter-defibrillator experienced asystole approximately 17 seconds after radiofrequency treatment was initiated.Cardiopulmonary resuscitation (cpr) was performed and the patient was successfully resuscitated.The procedure was stopped.Information notes: patient with pacemaker implantable cardioverter-defibrillator (icd).Boston scientific pacemaker icd representative was contacted prior to procedure.Magnet was given to staff from boston scientific representative the day before the procedure and was placed on patient pacemaker icd prior to starting procedure.Grounding pad placed on right flank/lower back.The disposable (or diros) trident radiofrequency hybrid insulated cannula dtrh length unknown.No issue during sensory testing.No issue during motor testing.Additional information received 04-sep-2026 the generator that was used at another location.Magnet placement was verified prior to initiating treatments.At the time of asystole the rfa temperature setting was 80 celsius.
Additional Manufacturer Narrative
The reported complaint product was returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 23-sep-2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: COOLIEF Cooled RF Advanced Generator
• Common Device Name: Generator, Lesion, Radiofrequency
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Stellartech Research Corp.; 560 cottonwood dr; milpitas CA 95035
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50872969
• Report Number: 3011270181-2026-00174
• Device Sequence Number: 21188684
• Product Code: GXD
• UDI-Device Identifier: 00193493473014
• UDI-Public: 00193493473014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: CRG-ADVANCED
• Device Catalogue Number: CRG-ADVANCED
• Device Lot Number: STZ1968-012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Pacemaker ICD; Trident Diros Probe
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Sex: Female