MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NATUS LUMBAR DRAINAGE CATHETER KIT II; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	NT821707
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Over 70-year-old male with history of rectal cancer status post colectomy being worked up for possible normal pressure hydrocephalous.Patient underwent fluoroscopic guided intrathecal drain placement.Post procedure there was concern that the drain was not draining.Patient was brought back to procedure and underwent fluoroscopic guided intrathecal drain evaluation with removal that same day.Segmental defect within the lumbar drain catheter was identified.During removal the catheter broke.The intrathecal segment was successfully removed.No known harm to the patient.

• Brand Name: NATUS LUMBAR DRAINAGE CATHETER KIT II
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd; san diego CA 92121
• MDR Report Key: 20513874
• Report Number: 20513874
• Device Sequence Number: 13069430
• Product Code: JXG
• UDI-Device Identifier: 00382830050531
• UDI-Public: (01)00382830050531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2024
• Report Date (Section F): 09/30/2024

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
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001054907
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 09/30/2024