MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX827T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

Conclusion information: an investigation was not possible because no product was sent for investigation.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the m.Blue®, since this documentation indicates that the valve is in perfect condition.With reference to the reason for the complaint, we would like to point out that deposits in the valve could be responsible for the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.Further actions: additional actions will be implemented in form of a authorities notification.

Event Description

It was reported that a m.Blue (#fx827t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt showed a under-drainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 75 years; weight: 61 kilograms; height: 160 centimeters; gender: female.

Manufacturer Narrative

Visual inspection: during the investigation, scratches on the outer housing of the valve, but no significant deformations or damage was determined.Permeability test: a permeability test has shown that all components are permeable.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 both the horizontal as well as the vertical positions.The results show that the m.Blue operates within the accepted tolerance in both positions.Adjustment test: the m.Blue valve was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found in m.Blue results: based on our investigation results, we can determine a non-adjustability at the m.Blue.The visible deposits in the valve may have led to the functional impairment.Deposits caused by substances naturally present in the patient's bodies, such as protein, blood or tissue particles, 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.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: M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR
• Type of Device: 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: 18048704
• MDR Text Key: 327129343
• Report Number: 3004721439-2023-00322
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504618
• UDI-Public: 4041906504618
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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
• Device Operator: Health Professional
• Device Model Number: FX827T
• Device Catalogue Number: FX827T
• Device Lot Number: 20061400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 61 KG