MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 6FR/49 CM, 5PCS; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	6883898
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ventilation in nava (neurally adjusted ventilatory assist) mode, a gastric perforation with the edi catheter occurred.There was no patient harm.Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
Report was received concerning neonatal gastric perforations in patients weighing <750 grams.The report was submitted with limited clinical information and patient outcome was not fully described.Perforation was confirmed but no additional clinical course details have been made available.Feedback from the healthcare facility has not claim causality between the edi catheter and the perforation.The customer acknowledges possible coincidence given widespread use of edi catheters in their nicu.From our postmarket surveillance data there is no trend identified indicating increased rates of gastric perforation associated with edi catheters.Current labelling has been reviewed and is consistent with the observed events as the edi catheter instructions for use (ifu) list gastric perforation as a rare adverse event.In conclusion based on the limited information provided, no causal link can be established between the reported gastric perforation and the use of the edi catheter.Device performance issues were not reported, and no device malfunction was alleged.The events remain consistent with known clinical risks associated with neonatal gastric perforation and are covered by existing product labelling.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER ENFIT 6FR/49 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: 22975702
• Report Number: 8010042-2025-0001367
• Device Sequence Number: 21219805
• Product Code: PIF
• UDI-Device Identifier: 17325710004606
• UDI-Public: (01)17325710004606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6883898
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown