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

Model Number	42-9551TRAK2
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Death
Event or Problem Description
It was reported the naso-jejunal (nj) tube was placed with the new magnetic device.The caregivers were "concerned as the tube became stiff very quickly." the patient ended up having a replacement on (b)(6) 2025 which was "only around 3-months later." moreover, when interventional radiologist (ir) went to replace it, the tube had ruptured, and a segment had broken off and was lodged in the duodenum making it difficult for a further nj to be sited by ir.The patient was "not fit enough for [a] ogd [oesophago-gastro-duodenoscopy] to remove it." the patient "died shortly after the procedure from aspiration pneumonia.It was noted the patient was "admitted with an ugi [upper gastrointestinal] bleed.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 03-apr-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.
Additional Manufacturer Narrative
Additional information: b5.All information reasonably known as of 23-jul-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
Additional information received 22-april-2025 stating the cause of death was respiratory infection and heart failure.The patient also had a gastro-intestinal bleeding.The end section of the tube had fractured off when clincians removed it and could be seen to be retained in the duodenum.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30277235, 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 22-aug-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.Attachments & outputs.

• Brand Name: CORTRAK 2 NG/NI FEED, ELECTROMAGNETIC 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21762911
• Report Number: 9611594-2025-00074
• Device Sequence Number: 20954915
• Product Code: KNT
• UDI-Device Identifier: 00350770460987
• UDI-Public: (01)00350770460987(240)120004773(17)280820(10)30277235
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: 42-9551TRAK2
• Device Catalogue Number: 42-9551TRAK2
• Device Lot Number: 30277235
• Was Device Available for Evaluation?: No
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 07/24/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Female