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

Model Number	CRI-17-100
Medical Device Problem Codes	High impedance (1291); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
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 27oct2017 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.(b)(4).
Event or Problem Description
It was reported that a "physician performed a coolief lumbar procedure.After completing the procedure and the needles removed, the physician noticed the orange plastic sheath covering the needle was peeled back.The physician had trouble inserting the needle initially but finally got it through the skin.Also, the physician noticed very high impedance levels burning with this defective needle.The patient was not harmed." no additional information was provided.

• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6985051
• Report Number: 8030647-2017-00115
• Device Sequence Number: 1197394
• Product Code: GXI
• UDI-Device Identifier: 10680651442083
• UDI-Public: 10680651442083
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: Physician
• Device Model Number: CRI-17-100
• Device Catalogue Number: 991039320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Patient Sequence Number: 1