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

Model Number	69007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A male patient with a spinal cord injury at the c5 level and neurogenic bowel, followed by chronic constipation, has been prescribed the navina classic rectal irrigation system with a balloon catheter.The patient has been using the navina system since 2022, with a water irrigation volume of 1000 ml.Recently, the patient noticed several balloon bursts in the rectum, all involving catheters from the same lot number.Although there were no medical complications from the balloon bursts, the patient experienced a pressure in the rectum when the balloon burst.
Additional Manufacturer Narrative
The batch documentation and returned devices were evaluated.No previous complaints for the lot number or any defects on the returned catheters were identified.The user appears to have a reflexic bowel due to a spinal cord injury (sci) at the c5 level.This type of sci interrupts the communication between the bowel and the brain, which is usually mediated by the spinal cord.Below the level of injury, the spinal cord still coordinates bowel reflexes.Stool buildup or the introduction of water through the rectum can trigger a reflex bowel movement without warning.This reflex action may explain the "pressure build-up" experienced by the patient.Consequently, this may cause the bowel to spasm and expel the balloon or potentially cause it to burst.

• 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; p.o. box 14; mölndal, se-43121 ; SW
• MDR Report Key: 20922725
• Report Number: 3009632672-2024-00021
• Device Sequence Number: 15525167
• Product Code: KNT
• UDI-Device Identifier: 07333387027364
• UDI-Public: 07333387027364
• 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): 12/13/2024

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: Lay User/Patient
• Device Expiration Date: 03/02/2026
• Device Model Number: 69007
• Device Catalogue Number: 6900740
• Device Lot Number: 653904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (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
• Patient Race: White