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

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Perforation (2001); Pneumothorax (2012)

Event Date 04/03/2019

Event Type  Death  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 01 may 2019 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported "we have had another patient event related to cortrak insertion.Patient developed a pneumothorax after cortrak was inserted into the lung.Additional information received 23-apr-2019 indicated the patient status is deceased.Right lung involvement.Medical intervention included chest tube placement and intubation.In regards to the cause of death, the complainant stated on (b)(6) 2019, "i cannot speculate in the cause of death but it appears there were many circumstances that contributed to death.".

Manufacturer Narrative

The correct serial number for the reported device was received on (b)(6) 2019.See section d4 for the serial number.The device history record for serial number (b)(4) was reviewed and the product was produced according to product specifications.The investigation is in progress.All information reasonably known as of (b)(6) 2019 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 halyard health 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

The actual complaint product was returned for evaluation.After the setup of the cortrak system and the completion of the initialization, the functionality of the returned unit performed as intended.Multiple tracings pulled from the cortrak system dated on the date of the reported event were noted to have the potential right lung placement.All information reasonably known as of 19 jun 2019 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 halyard health 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 Description

Clarification of the event description is as follows: an unknown feeding tube was used with the cortrak eas (enteral access system).The unknown feeding tube was inserted into the patient's lung.The cortrak eas confirms bedside tube placements without x-ray.

Manufacturer Narrative

This report is submitted to provide clarification to section b5.The investigation remains in progress.All information reasonably known as of 13 jun 2019 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 halyard health 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 ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8571343
• MDR Text Key: 143791113
• Report Number: 3006646024-2019-00008
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651472011
• UDI-Public: 10680651472011
• Combination Product (y/n): N
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2019

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
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720103
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/09/2019; 06/13/2019; 06/19/2019
• Supplement Dates FDA Received: 06/05/2019; 06/13/2019; 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 78