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

Model Number	12FR/125 CM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during nava (neurally adjusted ventilatory assist) mode of ventilation, when the edi catheter was removed from the patient, it broke leaving the tip in the stomach.A gastroscopy was necessary to remove the broken tip.The final patient outcome was no harm.Manufacturer's ref #: (b)(4).
Event or Problem Description
Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
No parts of the edi catheter was returned.Therefore, the investigation consists of an evaluation of available information and the provided pictures.There was reportedly no problems inserting the edi catheter, which was used for monitoring and ventilation in nava mode.The edi catheter was used for both feeding and medication and daily aspiration with no documented problem, which indicates that the edi catheter was functional during the ventilation period.The provided pictures showed that the distal end part of the edi catheter was broken off and both parts were discolored.There was no visible swelling.According to received information, the edi catheter was used over 20 days, which exceeded the recommended duration of usage of 5 days as outlined in the user¿s manual.It was also stated that a lubrication of the edi catheter had been used.The user¿s manual states as an important note that no other substance than water should be applied to the edi catheter.Other substances (lubricants, gels or any other solvents) might destroy the hydrophilic coating and disturb the contact with the electrodes.A check of the material parameters for the edi catheter showed that all parameters were within the specified limits during manufacturing.The product met the final release criteria.There were no non-conformities identified with the batch.The cause of breakage of the edi catheter when it was extracted has not been conclusively determined but a combination of effects from the surrounding chemical and biological environment in the stomach could have caused or contributed to the breakage.The effects of the extended duration of use and lubrication on the material have not been determined but it cannot be ruled out that it could have been a contributing factor.H3 other text : 4117.

• Brand Name: ENFIT EDI CATHETER
• 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: 16767909
• Report Number: 8010042-2023-00761
• Device Sequence Number: 3252347
• Product Code: PIF
• UDI-Device Identifier: 17325710004668
• UDI-Public: (01)17325710004668
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (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): 04/19/2023

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: 12FR/125 CM
• Device Catalogue Number: 6883903
• Device Lot Number: N/A
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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: Required Intervention
• Patient Sex: Unknown