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

Model Number MCK3-17-100-4

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

Patient Problem Staphylococcus Aureus (2058)

Event Date 10/18/2017

Event Type  Injury  

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 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.

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 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.

• Type of Device: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7069383
• MDR Text Key: 93282565
• Report Number: 8030647-2017-00136
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 10680651405903
• UDI-Public: 10680651405903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 95