MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN RF PROBE; COOLED RF PROBES AND CANNULAS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 21-feb-2019 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).

Event Description

It was reported that a professional literature review a report of the first significant infectious complication of genicular nerve radio frequency ablation (rfa)." summary: the patient had multiple co-morbidities including coronary artery disease with drug-eluding stents, hypertension, diabetes, morbid obesity, osteoarthritis of both knees, and a recent though apparently resolved history of a leukocytosis of unknown origin.The patient underwent an uneventful bilateral coolief rfa of the knees and reported immediate pain relief.However, within 24-hours, the patient reported "fullness" and increasing pain of the left knee.The patient went to the emergency room (er) where a knee aspiration was performed for 60cc of purulent fluid which was positive for staphylococcus aureus.The patient underwent three months of intravenous (iv) antibiotic therapy until the patient was pronounced clear of infection and two months later the patient underwent a left total knee arthroplasty.The authors for the literature review speculate that they traversed the joint capsule during cannulation (with the electrode remaining extra-articular), allowing for the introduction of bacteria into the joint capsule.They stress the importance of vigilance in maintaining sterile technique, considering prophylactic antibiotics, as well as suggesting that a more angular approach might make traversing the joint capsule less likely.Letter to the editor in "american academy of pain medicine-oxford academic.Article entitled "septic arthritis following radiofrequency ablation of the genicular nerves", authored by drs.Ankur khanna, nigel know, and nitin sekhri, published 28-jan-2019.

• Brand Name: UNKNOWN RF PROBE
• Type of Device: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 8359390
• MDR Text Key: 136850542
• Report Number: 8030647-2019-00027
• Device Sequence Number: 1
• Product Code: JOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR