MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG MININAV SET PED.5 W.VENTRICULAR CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV667T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On(b)(6)2026 miethke received the information about a complaint regarding a mininav from c.H.U.De toulouse.The hospital reported that the implanted valve showed drainage problems.The patient underwent a revision procedure on august 04, 2026.No patient complications were reported as a result of the revision procedure.The device is not available for examination.
Additional Manufacturer Narrative
Due to the limited information and the missing product investigation is restricted to traceability of manufacturing and quality control data.Based on the production records, a defect at the time of delivery of the mininav is excluded.The traceability indicates that the shunt was in perfect condition.Regarding similar complaints where we could examine the samples, it could be determine that the most frequent cause for a deterioration in the function of the product is deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve if aggregated in the valve.A final clarification of the cause what has led to drainage problems is only possible by an examination.

• Brand Name: MININAV SET PED.5 W.VENTRICULAR CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): Christoph Miethke GmbH & Co KG; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• Manufacturer (Section G): Christoph Miethke GmbH & Co KG; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• MDR Report Key: 50913373
• Report Number: 3004721439-2026-00275
• Device Sequence Number: 12104926
• Product Code: JXG
• UDI-Device Identifier: 04041906133153
• UDI-Public: (01)04041906133153(11)251006(17)300612(10)20085662
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: FV667T
• Device Catalogue Number: FV667T
• Device Lot Number: 20085662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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: Required Intervention
• Patient Sex: Unknown