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

Model Number	NT821707
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On [redacted], ir [interventional radiology] physician reported unsuccessful fluoroscopically guided lumbar drain placement complicated by a short fragment of distal drain sheared off into posterior epidural space (small foreign body).Ct cath fragment retained 2.5cm and diameter of 0.2cm in right dorsal epidural spaced.Level l3-4.Procedure aborted and no safe way of percutaneous retrieval.Discussed with neurology md team.Discussed with patient and several family members at great length.On the next day [redacted], pt was taken to surgery for csf [cerebrospinal fluid] leak repair (unrelated to this event) and neurosurgeon was able to remove the retained drain fragment, but it was unfortunately discarded by surgery team.No harm or deviation in care.

• Brand Name: NATUS LUMBAR CATHETER KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 6225 nancy ridge dr; san diego CA 92121
• MDR Report Key: 22148640
• Report Number: 22148640
• Device Sequence Number: 15363273
• Product Code: JXG
• UDI-Device Identifier: 00382830050531
• UDI-Public: (01)00382830050531
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025
• Report Date (Section F): 05/27/2025

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: Health Professional
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001039912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 05/27/2025