MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 12FR/125 CM, 5PCS; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	6883903
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Anxiety (2328); Discomfort (2330)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was receiving neurally controlled nava treatment where a naso-gastric edi catheter is used for transfer of electrical activity of the diaphragm (edi signal) to the ventilator system.The patient suddenly had episodes of vomiting where a piece of the edi catheter was found in the gastric content.The patient experienced discomfort, pain and anxiety.The edi catheter was removed, and follow-up chest x-ray showed a residual catheter piece in the gastric cavity.There is no indication for endoscopic removal.Final patient outcome was no harm.Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
Based on the information collected to date, it has been clarified that the edi catheter was inserted and in use from (b)(6) 2025 until the event date july 2, 2025.The patient had indications of swallowing difficulties and experienced episodes of vomiting, one of which a five cm piece of the edi catheter was found in the gastric content.The edi catheter was removed, and follow-up chest x-ray showed a residual catheter fragment in the gastric cavity.There was no indication for endoscopic removal.The final patient outcome was no harm.The subjected edi catheter was discarded and therefore not available for technical analysis.Further information regarding the usage was requested from the healthcare facility but no response was received.There have been no reports of difficulties inserting the edi catheter or issues with nava ventilation during the time the edi catheter was in use.Photos of the edi catheter was provided.The distal tip measuring approximately 5 cm was broken off and discolored, without visible swelling.The remaining part of the edi catheter was also discolored without swelling.The edi catheter was used for nine days, which exceeded the recommended maximum usage duration of five days as outlined in the users manual.Since the batch number was not provided, a check of the material parameters from manufacturing records for the subjected edi catheter could not be performed.In conclusion, there are no indications of an edi catheter malfunction.The cause of breakage of the edi catheter has not been conclusively determined but a combination of effects from the surrounding chemical and biological environment in the stomach and the extended duration of use could have caused or contributed to the breakage.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER ENFIT 12FR/125 CM, 5PCS
• Common Device Name: 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: 22553757
• Report Number: 3013876692-2025-00056
• Device Sequence Number: 15864819
• Product Code: PIF
• UDI-Device Identifier: 17325710004668
• UDI-Public: (01)17325710004668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025
• Report Date (Section F): 09/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6883903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 6 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/19/2025