MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821707, DRAINAGE KIT, LUMBAR

Model Number	NT821707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint#: (b)(4).The lot# was not confirmed.Per doc: (b)(4) rev 05 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.Further investigation to be carried out.
Event or Problem Description
Nt821707 - the doctor placed a lumbar catheter; the catheter was primed with saline.Upon removal, catheter was difficult to pull back.The catheter sheered.Ct imaging obtained, two pieces remain in patient.Neurosurgery consulted to determine if surgery for removal is needed.
Additional Manufacturer Narrative
Follow up report 002 ref to natus complaint # (b)(4).Correction: reference to capa005401 is not applicable.There is no associated capa.Additional information included in this follow up: expiration date: 07 apr 2026, sterile date (ref.Section d4) and manufacturer date (ref.Section h4).Device history record review: unit has passed all the required tests.No manufacturing defects or non-conformances observed.
Event or Problem Description
On nt821707 - the doctor placed a lumbar catheter, the catheter was primed with saline.Upon removal, catheter was difficult to pull back.The catheter sheered.Ct imaging obtained, two pieces remain in patient.Neurosurgery consulted to determine if surgery for removal is needed.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Complaint history review/trend analysis: (24 months review and percent of sales) 1 previously confirmed "integ-broke in use" complaints within the past two years.(b)(4) nt821707 units sold within past two years.Failure rate = (b)(4).A review of (b)(4) medical device hazard analysis (rev 05), identifies the hazard situation as "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." the risk level is considered moderate.Based on complaint of "lumbar catheter sheared off during removal" this determination is based on the information received from the customer.Root cause/failure investigation: the complaint was confirmed; the return product was torn from the tip where the perforations are located.The silicone catheter was stretched and most likely sheared by the beveled needle used to facilitate the insertion.There were previous incidents reported where the catheter sheared, capa005401 was generated to investigate.Findings as below: evaluation of the complaint description and product tested performed found the most likely cause of the lumbar catheter failure is due to its retraction during initial placement in the patient (either with or without the guidewire still populated in the catheter) while the tuohy needle remained in position.This resulted in the sharp heel edge of the tuohy needle cutting through the lumbar catheter.The instructions for use (b)(6) (rev.Ac) contain several warnings to help prevent this from occurring in the field: page (5) five warning states: "to avoid damage to the catheter, care must be taken not to withdraw the catheter from the needle in order to reposition it in the subarachnoid space.If the catheter must be removed, withdraw the needle and catheter simultaneously".Page (5) five under precautions states: "silicone rubber tears and cuts easily.Use rubber shod forceps when handling the catheter".Page seven (7) warns: "warning: to minimize the risk of damage to the catheter, take care not to pull back on or withdraw the catheter after insertion into the needle.If the catheter must be removed, withdraw the needle and catheter simultaneously".Also, page seven (7) below step 7 list three caution statements: "caution: silicone tears and cuts easily.Use rubber shod forceps when handling silicone catheters"."caution: hold the catheter securely at the exit site during needle and guide wire removal to prevent catheter dislodgement"."caution: follow these points to aid needle and guide wire removal and_ to prevent damaging the catheter".Based on the investigation findings it appears that the user failed to comply with the precautions, warnings and multiple cautionary statements outline throughout the instructions for use.Failure mode: confirmed / catheter tip sheared during use.
Event or Problem Description
Nt821707, the doctor placed a lumbar catheter; the catheter was primed with saline.Upon removal, catheter was difficult to pull back.The catheter sheered.Ct imaging obtained, two pieces remain in patient.Neurosurgery consulted to determine if surgery for removal is needed.

• Brand Name: NT821707, DRAINAGE KIT, LUMBAR
• Common Device Name: NT821707, DRAINAGE KIT, LUMBAR
• 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: 22023337
• Report Number: 2023988-2025-00042
• Device Sequence Number: 15714075
• Product Code: JXG
• UDI-Device Identifier: 00382830050531
• UDI-Public: 00382830050531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964923
• 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,Followup
• Report Date (Section B): 07/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2026
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001082988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/08/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male