MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FEEDING TUBE, ELECTRO STYLET, ENFIT CONNECTOR; DH CORTRAK DISPOSABLES

Model Number	42-9551TRAK2
Medical Device Problem Codes	Material Puncture/Hole (1504); Malposition of Device (2616)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 21-nov-2025 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.
Event or Problem Description
It was reported that during placement of a nasojejunal (nj) tube, the guidewire perforated the tube and caused trauma to the esophagus of the patient.Additional information received 03-nov-2025.Stated while the clinician was inserting the nj tube on an intensive care unit (icu) patient, "large fundal coil noted on screen, slowly pulled wire and tube back until coil removed.On re-inserting wire into tube, the wire moved unusually and very suddenly forward."[the clinician]" instantly removed the tube from the patient and found 10+cm of electromagnetic wire has perforated the tube.The tube was likely perforated whilst in the patient's esophagus (35cm)."[the clinician]" stopped the procedure and spoke with the icu consultant immediately.Patient had localized bleeding, the ng was aspirated, and it was blood stained/blood containing.".

• Brand Name: CORTRAK 2 NG/NI FEEDING TUBE, ELECTRO STYLET, ENFIT CONNECTOR
• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23625002
• Report Number: 9611594-2025-00297
• Device Sequence Number: 13019694
• Product Code: KNT
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-9551TRAK2
• Device Catalogue Number: 42-9551TRAK2
• Device Lot Number: 20131775
• Date Returned to Manufacturer: 11/17/2025
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORTRAK EAS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 134 LB