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

Model Number	6900540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the batch records for the navina classic control unit identified no manufacturing deviations or nonconformities.No similar complaints have been reported for this lot.The returned device was functionally tested, including balloon inflation (2 pumps) and irrigation with 500 ml of water.The device performed as intended and met all specifications.No device malfunction was identified.The rectal catheter used during the event was not returned and could not be evaluated.Available information indicates that the irrigation procedure involved multiple catheter insertions, repeated balloon inflations following catheter expulsion, and reported resistance during insertion, along with observation of blood prior to completion of irrigation.The procedure was performed by a caregiver during their first independent use of the device.Complete procedural details could not be confirmed, as the user declined to provide additional information.The patient has significant preexisting medical conditions, including neurogenic bowel and an extensive history of abdominal and urological surgeries, which may increase susceptibility to bowel injury.Based on the available evidence, no device deficiency has been identified.The root cause of the event cannot be definitively determined; however, procedural factors and patient-specific conditions may have contributed.The manufacturer will continue to monitor for similar events and will update this report if additional relevant information becomes available.
Event or Problem Description
A 28-year-old patient experienced a bowel perforation following transanal irrigation with a navina classic system and rectal balloon catheter on (b)(6) 2026.The procedure was performed at home by a newly trained nurse during her first independent use.During the procedure, the catheter was inserted and the balloon inflated (2 pumps).The catheter was expelled with the balloon still inflated.After deflation, the catheter was reinserted and reinflated; however, it was again expelled with the balloon inflated.A third insertion attempt was made, during which resistance was encountered and minor bleeding was observed.Irrigation was subsequently performed in two interrupted attempts with approximately 450 ml of water instilled.The patient developed symptoms immediately after the procedure and was transported to the emergency room the same day.The patient underwent surgical repair of a bowel perforation on (b)(6) 2026, followed by a second surgery for colostomy on (b)(6) 2026.The patient is currently hospitalized and stable.

• 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, sweden ; SW
• MDR Report Key: 25197527
• Report Number: 3009632672-2026-00019
• Device Sequence Number: 15694198
• Product Code: KNT
• UDI-Device Identifier: 07333387025803
• UDI-Public: 07333387025803
• 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
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 6900540
• Device Catalogue Number: 6900540
• Device Lot Number: 669569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic