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

Model Number CRK-17-50-2

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, m18127d215, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 26-apr-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 Description

Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with same unit, involving two different events.This is the first of two reports.Refer to 8030647-2019-00046 for the second event.It was reported that during a knee procedure, depth markers were removed from three introducers placed in the knee.During first ablation at anterior femoral site, machine kept signaling high impedance and the clinicians were unable to complete the procedure.The two other procedure sites were done without incident.The clinicians returned to the first site and attempted the ablation once again.The pain management generator continued to indicate warning message of high impedance.The introducer was pulled back slightly and ablation was able to be completed.When introducer was removed, it was noticed that the polyimide coating stayed in the patient.The physician was able to remove it.

Manufacturer Narrative

One sample device was received.The device was evaluated.The sample was received with a 19mm segment of the polyimide tubing detached from the introducer.The segments were examined under magnification.Both exhibited jagged ends, with peeling on the outer surface.The failure was confirmed.The investigation concluded this appears to be isolated and use error is a potential root cause.All information reasonably known as of 09-jul-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).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 an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: COOLIEF COOLED RADIOFREQUENCY KIT
• Type of Device: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8568999
• MDR Text Key: 146680865
• Report Number: 8030647-2019-00045
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 10680651441956
• UDI-Public: 10680651441956
• Combination Product (y/n): N
• PMA/PMN Number: K053082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: CRK-17-50-2
• Device Catalogue Number: 104419500
• Device Lot Number: M18127D215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 128