MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE; DH CORTRAK DISPOSABLES

Model Number 40-9431TRAK2

Device Problems Material Rupture (1546); Stretched (1601)

Patient Problems Shock (2072); Foreign Body In Patient (2687); Gastrointestinal Hemorrhage (4476); Melena (4480); Stomach Ulceration (4488); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.A root cause could not be determined.All information reasonably known as of 10 jan 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.

Event Description

It was reported, dobhoff (dht) nasogastric tube removed by physician during esophagogastroduodenoscopy (egd).It was observed by bedside nurse that dht had separated into two pieces.Both pieces were removed by physician.Tubing appeared to have ballooned and then ruptured at some point during use.Images of patient¿s chest x-rays, which were completed during patient¿s stay in the icu, were reviewed and was unable to determine when the incident occurred.No injury reported.

Event Description

Per additional information received on 23feb2024, ¿the medical examiner¿s autopsy report noted that patient had a complicated hospital course for treatment of thermal burns.It does suggest that primary evidence of death was due to patient¿s thermal injuries and not a gastrointestinal (gi) bleed.The gi bleed was indirectly related as a complication of treatment.¿.

Manufacturer Narrative

All information reasonably known as of 13 mar 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.

Event Description

Additional information received on 12-jan-2024 reporting, the location of the break occurred at approximately the 60 cm mark.The broken tube was discovered during esophagogastroduodenoscopy (egd).The tube was inserted on (b)(6) 2023 and removed on (b)(6) 2023.Several chest x-rays and kidney, ureter, and bladder (kub) x-rays were reviewed during this time and there were no irregularities seen on images.For flushing, an 60 ml enteral feeding enfit tip syringe is typically used.There is no evidence to suggest that the dobbhof tube (dht) was readjusted and no evidence that stylet was reinserted into dht.The stylet was only left in place for kidney, ureter, and bladder x-ray (kub) and then removed for feedings thereafter.It was additionally reported that patient injury occurred.¿one oozing cratered gastric ulcer with oozing hemorrhage was found at the pylorus after broken dobbhof tube (dht) was removed.Broken dobbhoff tube with broken tip at the pylorus was causing ulceration.Patient required blood transfusion due to low hemoglobin from time of broke dht removal until death.¿ gastroenterology (gi) was consulted on (b)(6) 2023 due to melena in stool.Egd was performed and dht was removed with rat-toothed forceps.¿ulceration was treated with bipolar cautery.Patient placed on pantoprazole drip.Increased pressor requirements.On (b)(6) 2023 gi was consulted for second time due to down trending hemoglobin and was presenting with hemorrhagic shock secondary to upper gi bleeding (ugib).A second egd was completed.It was found that there was one oozing cratered gastric ulcer with a visible vessel found at pylorus in same area as before.Intervention was required on this date as well to stop bleeding.The patient died on (b)(6) 2023.

Manufacturer Narrative

The sample is reported to be available but has not yet been received by the manufacturer.All information reasonably known as of 23 jan 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 21 cfr 803, 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

Per additional information regarding sample return status reported on (b)(6) 2024, ¿we have received the package.However, due to the severity of harm caused to the patient, we are unable to send it back at this time and must keep a legal hold on it for now.¿ all information reasonably known as of 06 feb 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 comp (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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE
• Type of Device: 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18489148
• MDR Text Key: 332998103
• Report Number: 9611594-2024-00004
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460475
• UDI-Public: 00350770460475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9431TRAK2
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG