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

Model Number ENFIT 12FR/125 CM

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2023

Event Type  Injury  

Event 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.An endoscopy was necessary to remove the residual tip.The final patient outcome was no harm.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

There was reportedly no problems inserting the edi catheter, which was used for monitoring and ventilation in nava mode.The edi catheter was not used for feeding, medication or aspiration where a different nasogastric tube was used instead.The nava ventilation worked normally with clean edi waveforms until the last day prior withdrawal when noise was noted on the edi waveform.The edi catheter was returned for investigation.The distal tip measuring 9 cm was broken off and discolored.There was no visible swelling.The electrodes were missing.Due to the damages no further functional testing could be performed.According to received information, the edi catheter was used for 13 days, which exceeded the recommended duration of usage of 5 days as outlined in the user¿s manual.A check of the material parameters for the subjected 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.There are no indications of an edi catheter malfunction.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 and the extended duration of use could have caused or contributed to the breakage.

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: 17610947
• MDR Text Key: 321819856
• Report Number: 8010042-2023-01644
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENFIT 12FR/125 CM
• Device Catalogue Number: 6883903
• Device Lot Number: 3000231967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening