MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA CLASSIC SYSTEM; NAVINA CLASSIC SYSTEM REGULAR

Model Number	68940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event involves repeated balloon rupture during use of the navina rectal catheter regular under conditions of normal use as described by the patient.A review of production and quality records for the affected lot confirmed that all manufacturing and release criteria were met.No deviations or nonconformities were identified.Review of complaint data determined that no similar events have been reported for this lot.Returned device samples were evaluated, and no material or manufacturing defects were identified that could account for the reported failures.The patient reported temporary discontinuation of prescribed pregabalin medication coinciding with the onset of the events, with subsequent reduction in frequency after resumption of treatment.While this represents a potential contributing factor, a direct causal relationship cannot be established.Based on the available information, no root cause has been confirmed.The event will continue to be monitored through post-market surveillance and complaint trending activities.
Event or Problem Description
A patient using the navina classic transanal irrigation system with navina regular rectal balloon catheters reported repeated balloon ruptures during use.The patient indicated that during a single day of use, approximately six catheters experienced balloon rupture while in situ.Over the subsequent six days, the patient required the use of approximately two catheters per day due to similar failures.The reported balloon ruptures occurred either immediately during balloon inflation or within 1-2 minutes following inflation during the irrigation phase.The patient stated that the device was used according to the instructions for use, with no perceived resistance during insertion and confirmation that the balloon was fully positioned within the rectum prior to inflation.The patient reported performing approximately 5-6 pump strokes for balloon inflation, followed by irrigation for approximately 7-8 minutes.The patient reported associated symptoms including mild rectal bleeding (described as a few drops observed in the toilet) occurring immediately following at least one balloon rupture, as well as rectal discomfort and pain persisting over a period of approximately 4-5 days.The patient denied any known history of hemorrhoids, fissures, or diagnosed rectal inflammation.No changes in device storage conditions were reported; products were stored at room temperature (70-71°f) with no exposure to extreme environmental conditions.All affected devices were from the same lot ; however, the patient reported that some catheters from the same order functioned as expected.The patient subsequently reported that, coinciding with the onset of the events, a prescribed medication (pregabalin) had been unintentionally discontinued.After resuming the medication, the patient noted a decrease in the frequency of balloon ruptures.

• 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 ; aminogtan 1; p.o.box 14; molndal, se-43 121 molndal ; SW
• MDR Report Key: 25027438
• Report Number: 3009632672-2026-00017
• Device Sequence Number: 18673606
• Product Code: KNT
• UDI-Device Identifier: 07333387024745
• UDI-Public: 07333387024745
• Combination Product (Y/N): N
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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
• Device Model Number: 68940
• Device Catalogue Number: 6894000
• Device Lot Number: 670827
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2026
• 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