MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	20-0950
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); Pneumothorax (2012); Irritability (2421)
Date of Event	02/06/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18-mar-2020 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.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.The device was not returned.
Event or Problem Description
It was reported a clinician not on the cortrak team attempted to insert a naso-intestinal (ni) tube with the cortrak device.The tracing showed the "tube obviously was going toward the right lung." a pneumothorax occurred.Additional information received 25-feb-2020 stated the "nurse on the core cortrak team was assisting.X-ray confirmed pneumothorax occurred." the user facility did not realize there was an issue until the patient became agitated a few hours later.Again, an x-ray was taken and confirmed a pneumothorax.A chest tube was placed in the patient.The patient was intubated due to respiratory failure related to his disease.The patient had end stage chronic obstructive pulmonary disease (copd) and died, on (b)(6) 2020 at 13:50, from issues unrelated to the pneumothorax.
Additional Manufacturer Narrative
The device history record for the reported lot number, 1708005, 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 24-jun-2020 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
Software release 2.4.8.H6: investigation findings: 4247- appropriate term/code not available: usage problem identified the actual complaint product was returned for evaluation.The sample evaluation determined that the unit was functioning as intended.The tracing provided did not follow typical placement pattern, and customer confirmed operator was not trained and lung deviation could be seen on monitor unit screen.The root cause was determined to be user-incorrect use.All information reasonably known as of 12 apr 2024 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.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): CORPAK MEDSYSTEMS, INC. A DIVISION OF AVANOS; 1001 asbury dr; buffalo grove IL 60089
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 9849317
• Report Number: 3011270181-2020-00048
• Device Sequence Number: 19529732
• Product Code: KNT
• UDI-Device Identifier: 10680651472011
• UDI-Public: 10680651472011
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2024

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: 20-0950
• Device Catalogue Number: 104720112
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 04/12/2024
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 06/25/2020; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEST TUBE PLACED.; CHEST TUBE PLACED
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 81 YR
• Patient Sex: Male