MAUDE Adverse Event Report: AVANOS MEDICAL INC. COOLIEF COOLED RADIOFREQUENCY KIT; COOLED RF PROBES AND CANNULAS

Model Number	CRK-17-50-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).The device was not returned.
Event or Problem Description
It was reported the physician performed a genicular coolief radio frequency ablation (rfa) post total knee amputation (tka) patient on (b)(6) 2019.A minimal amount of fluid was aspirated from one of the introducer sites.Prior to injection of lidocaine and lesioning, the physician tried to aspirate the target again and had no fluid return.Lesioning was then performed "for the 2:30" with no issues with impedance, temperature or generator alarms.The patient was seen for a follow-up on 03-dec-2019 and reported increased pain in the knee.Upon examination, the physician noticed reddening of the skin around that site.The patient was admitted to the hospital and a fluid specimen was obtained and tested.It revealed no signs of infection as noted by the physician.Additional information received 06-dec-2019 state the patient was treated with a medrol dose pack and vancomycin.

• Brand Name: COOLIEF COOLED RADIOFREQUENCY KIT
• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9528259
• Report Number: 8030647-2019-00110
• Device Sequence Number: 14147609
• Product Code: GXI
• UDI-Device Identifier: 00193493440757
• UDI-Public: 00193493440757
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K053082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: CRK-17-50-4
• Device Catalogue Number: 104407500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79