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

Model Number 20-0950

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Pneumothorax (2012); Shock (2072)

Event Date 04/17/2021

Event Type  Death  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 1604010 was reviewed and the product was produced according to product specifications.All information reasonably known as of 15 feb 2022 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 complaint database and identified as complaint (b)(4).

Event Description

A pneumothorax was reported with the cortrak device; no additional information was provided.Additional information received on 28jan2022 reported that the patient was upgraded to the coronary care unit (ccu) and the physician was adamant that the cortrak be placed.When placing the cortrak it was hard for the registered nurse (rn) to track the tip of the device as the patient was agitated and moving during insertion.The patient reportedly went unresponsive and their pulse was lost; however, return of spontaneous circulation (rosc) was achieved.The patient was intubated and a stat frontal supine radiograph (kub) was ordered to confirm the placement of the cortrak, an xray confirmed the pneumothorax in the right lung.It was reported that the patient passed away on (b)(6) 2021 as a result of undifferentiated shock.

Manufacturer Narrative

The device history record for lot 1604010 was reviewed and the product was produced according to product specifications.The device was evaluated.A system placement test and devices test were performed and the device passed the tracing test.The placement failure could not be repeated.Root cause could not be determined.All information reasonably known as of 21 mar 2022 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 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.

Manufacturer Narrative

H6: investigation findings: 4247 appropriate term/code not available: usage problem identified correction: h10.The root cause was related to user : incorrect use.All information reasonably known as of 30 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
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MINNETRONIX, INC.; 1635 energy park dr.; saint paul MN 55108
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 13537507
• MDR Text Key: 285819034
• Report Number: 3011270181-2022-00009
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 20-0950
• Device Catalogue Number: N/A
• Device Lot Number: 1604010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RU 1612001
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Death; Disability
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 103 KG