MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821706, EXTERNAL DRAINAGE, LUMBAR CATHETER

Model Number	NT821706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821706, external drainage, lumbar catheter - lumbar drain catheter shearing off during placement with an unanticipated surgical procedure to remove the catheter remnants.Patient needed lumbar drain placed for csf leak.Access needle insufficient length for body habitus.Catheter shear during manipulations.Partial catheter piece and wire removed successfully after operative procedure.
Additional Manufacturer Narrative
Initial report ref to natus complaint#(b)(4).Per (b)(4) natus external drainage lumbar catheters - risk analysis spreadsheet (ras) hazard 1.5 - catheter tubing is cut by sharp inner edge of needle while accessing into lumbar spine and a catheter piece is left in the patient body.Effect (harm): surgical intervention.Residual risk: medium.The hazard identified have been reduced as far as possible, and the residual risk for this hazard is mainly associated with the surgical revision.The device's ifu contains the instructions, warnings, cautions, and precautions in order to use the device.Risk outweighed by benefit of use of device.No associated capas.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).It was confirmed there was no delay in surgery, injury or death, however additional medical intervention was required.The lot number of the affected product was not confirmed.Complaint history review/trend analysis: (24 months review and percent of sales) 0 previously confirmed "integ-broke in use" complaints within the past two years.2,986 nt821706 units sold within past two years.Failure rate = (b)(4).Root cause/failure investigation: the customer did not return the device for evaluation or provide additional information.No further action is required, complaints will be tracked and trended for recurring issues.Failure mode: no device returned - unable to determine.
Event or Problem Description
Nt821706, external drainage, lumbar catheter - lumbar drain catheter shearing off during placement with an unanticipated surgical procedure to remove the catheter remnants.Patient needed lumbar drain placed for csf leak.Access needle insufficient length for body habitus.Catheter shear during manipulations.Partial catheter piece and wire removed successfully after operative procedure.

• Brand Name: NT821706, EXTERNAL DRAINAGE, LUMBAR CATHETER
• Common Device Name: NT821706, EXTERNAL DRAINAGE, LUMBAR CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego 92121
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121
• MDR Report Key: 21915994
• Report Number: 2023988-2025-00032
• Device Sequence Number: 4184202
• Product Code: JXG
• UDI-Device Identifier: 00382830050524
• UDI-Public: 00382830050524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K910938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: NT821706
• Device Catalogue Number: NT821706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown