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

Model Number	MCK2-17-100-4
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, m7164d202, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.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).
Event or Problem Description
It was reported the physician was inserting the introducer into patient's lumbar area.The physician removed the introducer, inspected it and set it aside.It was noted that the copper colored "wrapping" on the introducer had been pushed up exposing more of the silver material.The physician had difficulty pushing the needle through the tissue and there was an odd feeling when she tried to advance it and that is what made her remove the introducer for inspection.The physician was unable to use it for the rest of the bilateral lumbar radio frequency ablation (rfa).
Additional Manufacturer Narrative
One fluid delivery introducer sample device was revived.No product packaging was received.The product did not contain a lot number.The device was evaluated and the failure was confirmed.The investigation was conduced and root cause was related to manufacturing.All information reasonably known as of 05-mar-2020 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).

• Brand Name: COOLIEF MULTI-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: 9528260
• Report Number: 8030647-2019-00109
• Device Sequence Number: 366451
• Product Code: GXI
• UDI-Device Identifier: 10680651405880
• UDI-Public: 10680651405880
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: MCK2-17-100-4
• Device Catalogue Number: 104058802
• Device Lot Number: M7164D202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1