MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBES; DH CORTRAK DISPOSABLES

Model Number	20-9551TRAK2
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.Sample evaluation confirmed the returned guidewire exhibited multiple bends and kinks; however, the associated tubing was not received, preventing full assessment of the reported issue.Reports on difficulty withdrawing the guidewire was unable to inspect or examined.The root cause could not be determined.(b)(6).All information reasonably known as of 27 mar 2026 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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.
Event or Problem Description
Primary registered nurse (rn) placed a cortrak enteral feeding tube initially without issue with tracing corresponding to gastric placement.The rn was unable to advance the tube further and experienced difficulty withdrawing the cortrak tube and guidewire.The device was removed and when the guidewire was removed from the tube it was observed to be bent.The guidewire was sequestered and given to unit leadership.A subsequent cortrak placement attempt was successful without issue.No patient harm was reported.

• Brand Name: CORTRAK 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBES
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24713977
• Report Number: 9611594-2026-00151
• Device Sequence Number: 17558929
• Product Code: KNT
• UDI-Device Identifier: 00350770458182
• UDI-Public: (01)00350770458182
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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 Model Number: 20-9551TRAK2
• Device Catalogue Number: 20-9551TRAK2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown