MAUDE Adverse Event Report: Wellspect HealthCare Navina Classic System; Navina Classic System Regular

Model Number	6900340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Caregiver reported that the balloon of a navina classic regular rectal catheter ruptured multiple times during use.The patient uses the navina system daily with approximately 500-600 ml of water and inflates the balloon using 1-2 pump strokes.The caregiver reported that the balloon rupture occurred during irrigation and that both the patient and caregiver could hear and feel the balloon rupture.No pain, bleeding, or other injury was reported.The patient has been using the navina system since 2024.The caregiver inserts the catheter, while the patient controls balloon inflation and water volume.
Additional Manufacturer Narrative
Additional information obtained during the investigation indicated that the reported balloon ruptures occurred with different production lots and during irrigation.No pain, bleeding, medical intervention, hospitalization, or other adverse clinical outcome was reported.The patient has a history of t12 spinal cord injury with paraplegia and neurogenic bowel.No known anorectal abnormalities, strictures, hemorrhoids, inflammatory bowel disease, or prior bowel surgery were reported.The device was not returned for evaluation.Review of manufacturing records and batch documentation for the reported lots did not identify any deviations or nonconformities, and all products met established release specifications.Exact root cause could not be determined based on the available information.

• Brand Name: Navina Classic System
• Common Device Name: Navina Classic System Regular
• Manufacturer (Section D): Wellspect HealthCare; aminogatan 1; p.o. box 14; molndal, se-43 121, molndal, sweden ; SW
• Manufacturer (Section G): Wellspect HealthCare; aminogatan 1; p.o. box 14; molndal, se-43 121, molndal, sweden ; SW
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14; molndal,, se-43 121 molndal P.O. -BOX ; SW P.O. BOX 1
• MDR Report Key: 50911077
• Report Number: 3009632672-2026-00024
• Device Sequence Number: 5803598
• Product Code: KNT
• UDI-Device Identifier: 07392532198403
• UDI-Public: 07392532198403
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 6900340
• Device Catalogue Number: 6900340
• Device Lot Number: 678378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male