MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 6 FR/49 CM

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Bowel Perforation (2668)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that the patient was ventilated in neurally adjusted ventilatory assist (nava) mode, with the use of a naso-gastric edi catheter.Nava is a patient-initiated breathing mode in which the breathing support is triggered by the patient's edi signal.The edi catheter is a single-use feeding tube with measuring electrodes positioned in the esophagus so that the measuring electrodes span the movement of the diaphragm.During feeding when using a stethoscope, air sound was noted in the stomach.Shortly after, the patient became bradycardic.X-ray performed showed a slightly high edi catheter.Attempts were made to push it back but not succeeded.An ordinary naso-gastric feeding tube was placed but it did not succeeded either.A chest x-ray performed showed a pleural effusion.A puncture of 7ml of air and 40ml of lactescent liquid was made.The user have a hypothesis of perforation on placement of naso-gastric edi catheter and that milk had been given in the pleura.Final patient outcome was no injury.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

The edi catheter was not returned for investigation.No x-rays, logs or position window screen shots from connected ventilator were received.The investigation therefore consists of an evaluation of available information.No problems were experienced during insertion of edi catheter with the help of x-ray on (b)(6) 2023.Later the same day during feeding, air sound was noted in the stomach.Shortly after, the patient became bradycardic and feeding stopped.X-ray performed showed a slightly high catheter position.Attempts were made to push the catheter back but not succeeded.An ordinary naso-gastric feeding tube was placed but it did not succeeded either.A chest x-ray performed showed a pleural effusion and a puncture of air and lactescent liquid was made from the pleura.There are many possible causes of gastric/intestinal perforation in the neonatal population, but there are no indications of an edi catheter malfunction.The edi catheter is designed in a way that catheter stiffness is as a proven gastric tube.The edi catheter also has a rounded tip and is covered with a hydrophilic coating to reduce friction when inserted into the patient.There is adequate information in the user¿s manual for calculating of the insertion length and correct positioning of the edi catheter.There is also a calculation tool in the ventilator to suggest the correct edi catheter for the patient and the insertion length.Most likely the perforation occurred during catheter placement and feeding was given in the pleura.It has not been possible to ascertain whether the edi catheter moved as a result of its securement becoming looser or due to any other factor.The source of the pleural effusion has not been able to be determined.H3 other text : 4117.

Event Description

Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 17050411
• MDR Text Key: 316411798
• Report Number: 3013876692-2023-00027
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6 FR/49 CM
• Device Catalogue Number: 6685775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2023
• Distributor Facility Aware Date: 09/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2023
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male