MAUDE Adverse Event Report: HALYARD HEALTH COOLIEF* MULTI-COOLED RADIOFREQUENCY KIT; COOLED RF PROBES AND CANNULAS

Model Number	MCK3-17-100-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Staphylococcus Aureus (2058)
Date of Event	10/18/2017
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 in progress.All information reasonably known as of 29nov2017 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that a patient had an infection post procedure where coolief probes were utilized.An infection was noted on (b)(6) 2017.The patient had a l4/l5 cooled rf procedure and admitted to hospital on (b)(6) 2017 with abscess noted at the site.Blood cultures were positive for staph infection.The patient is being treated with iv antibiotics, remains hospitalized.Additional information was received on 14-nov-2017 that states, the procedure was a right radiofrequency ablation of l2, l3, l4, l5.One kit was used and the "abscess" was identified at l4-l5.There was no immediate tissue reaction and steroids were not used.No additional information was provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, m7045d210, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.No root cause was identified at this time.All information reasonably known as of (b)(6) 2018 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 halyard health 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 halyard health.Halyard health 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 halyard health 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 a halyard health product is defective or caused serious injury.
Event or Problem Description
Additional information was received that states, the pain management director reported that the patient had been discharged one week after hospitalization, and sent home on iv antibiotics.

• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7069383
• Report Number: 8030647-2017-00136
• Device Sequence Number: 1301184
• Product Code: GXI
• UDI-Device Identifier: 10680651405903
• UDI-Public: 10680651405903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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 Expiration Date: 02/28/2021
• Device Model Number: MCK3-17-100-4
• Device Catalogue Number: 104059000
• Device Lot Number: M7045D210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 95