MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

Model Number	1104HMT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - during the implantation process, it was found that the silicone tube of the ventricular channel was broken.
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Per (b)(4) rev 05 camino110-4 series intracranial pressure/temperature catheters and accessories - risk analysis spreadsheet, (ras).Hazard id 6.4 silicone shears off catheter tip during insertion or removal: a) silicone material, tolerancing vs.Stylet, or silicone attachment insufficient / non-robust for intended use b) physician inadvertently tears silicon with stylet or catheter effects (harm): inflammation; local toxicity; systemic toxicity residual risk: minor.The hazards identified have been reduced as far as possible, and the benefit of use of the entire product outweighs the risks identified.Requested additional information from the customer, and awaiting response.Further investigation to be carried out.
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - during the implantation process, it was found that the silicone tube of the ventricular channel was broken.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Sterile date: (b)(6) 2023.Device history review: unit has passed all the required tests.No manufacturing defects or non-conformances observed.No associated capas.Risk management review: a review of (b)(4) medical device hazard analysis (rev 05), identifies the hazard situation as "6.4 silicone shears off catheter tip during insertion or removal: a) silicone material, tolerancing vs.Stylet, or silicone attachment insufficient / non-robust for intended use b) physician inadvertently tears silicon with stylet or catheter" based on complaint of "silicone tube ruptures." the risk level is considered low.This determination is based on the information received from the customer.Root cause/failure investigation: the customer did not return the device for evaluation or provide additional details regarding the device.The device history records show specifications were met prior to release of product.Complaint data will be tracked and trended for recurrence.No further action is required.Failure mode: n/a - not returned.

• Brand Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Common Device Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 23157907
• Report Number: 2023988-2025-00106
• Device Sequence Number: 14740906
• Product Code: GWN
• UDI-Device Identifier: 00382830047531
• UDI-Public: 00382830047531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962928
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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 Expiration Date: 08/25/2026
• Device Model Number: 1104HMT
• Device Catalogue Number: 1104HMT
• Device Lot Number: 118D01000800
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown