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

Model Number	69005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A foreign adverse event occurred outside the united states.A 53-year-old male patient, with a previous history of neurogenic bowel dysfunction due to spinal cord injury, was prescribed a navina classic system, a transanal irrigation system with a rectal balloon catheter.The patient and his caregiver received hands-on training, and the patient started the procedure by the caregiver's help.On (b)(6), during the irrigation procedure, the patient complained about pain, and bleeding was discovered during irrigation.The caregiver slightly removed the balloon catheter.It was confirmed by the caregiver that the balloon catheter did not burst.A day later, the patient was brought to the hospital, where he was diagnosed with bowel perforation, which required immediate emergency surgery.As of the date of this incident, the patient is recovering well after the stoma surgery.
Additional Manufacturer Narrative
The balloon durability test of the released product was successfully performed prior to batch release.Additionally, the actual device used will not be returned for physical investigation; therefore, the manufacturer is unable to establish an appropriate root cause for the involved product.However, we theorize that this incident could be a result of hydrostatic pressure created in the rectum, combined with the patient's underlying condition of spinal cord injury, which may have caused this serious injury.

• 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; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; mölndal, SE-43- 121 ; SW SE-43 121
• MDR Report Key: 21502060
• Report Number: 3009632672-2025-00008
• Device Sequence Number: 20834758
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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
• Device Expiration Date: 04/26/2026
• Device Model Number: 69005
• Device Catalogue Number: 6900576
• Device Lot Number: 657537
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian