MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG MININAV 5 SYS W/PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV697T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mininav shunt system (# fv697t) was implanted.According to the complainant, the shunt system showed an under-drainage.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 months weight: 5.2 kgs height: 55 cm gender: female.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the mininav, peritoneal catheter and the deflector, but bloody deposits and tissue residues on the ventricular catheter and the pedi sprung reservoir were determined.Permeability test: a permeability test has indicated that the ventricular catheter has a blockage while all other components were permeable.During the permeability test some particles and bloody liquid were flushed out.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the mininav operates within the accepted tolerances in the horizontal position.Internal inspection: after dismantling of the valve, deposits were found in mininav.Result: based on our investigation results, we can determine a blockage at the ventricular catheter.The visible deposits on the catheter have led to the occlusion.Furthermore, we were able to detect visible deposits in the mininav and in the pädi.Control reservoir.These deposits did not affect the technical properties at the time of the examination.Deposits of natural substances found in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins can impair the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: MININAV 5 SYS W/PED.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 20492504
• Report Number: 3004721439-2024-00318
• Device Sequence Number: 4174877
• Product Code: JXG
• UDI-Device Identifier: 04041906142667
• UDI-Public: 4041906142667
• Combination Product (Y/N): N
• Initial Reporter Country: RW
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 10/21/2024

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: 11/05/2023
• Device Model Number: FV697T
• Device Catalogue Number: FV697T
• Device Lot Number: 20072358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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 Age: 2 MO
• Patient Sex: Female
• Patient Weight: 5 KG