MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M. BLUE PLUS VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX804T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Visual inspection in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: no defects or other abnormalities are detected.Permeability test.To check if the m.Blue plus® is blocked, we have performed a permeability test on the shunt system.This test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the m.Blue plus® shunt system is permeable.Adjustability test.We have investigated whether the m.Blue and progav 2.0 can be successfully set to each specified pressure setting.Thus indicating whether the valves are fully adjustable within the full range of specified pressure settings (in increments of 4 cmh2o (m.Blue) and in increments of 5 cmh2o (progav 2.0) ).The m.Blue® and the progav® 2.0 were found to be adjustable to all pressure settings.Braking force and brake function test.The braking force and brake function test investigates whether the braking function of the adjustable valves is present and how much force must be exerted on the housing to release the rotor to adjust the valves using the integrated magnet of a specific measurement apparatus of braking force.The braking force of the both valves were within the specified tolerance and the brake function operated as expected.Internal inspection of product.In order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, clearly deposits were found in both valves.Results.Based on our investigation, we are not able to substantiate the claim of "non- adjustability".However, we assume that the significant deposits found within the valve may have temporarily caused 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.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

Event Description

It was reported that there was a problem with a m.Blue plus.The surgeon reported that: "programmable valve not adjusting.No patient harm".Patient information: age: (b)(6) years.Weight: (b)(6) kg.Height: unknown.Gender: male.Implantation: (b)(6) 2019.Removal: (b)(6) 2020.

• Brand Name: M. BLUE PLUS VALVE
• 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: 11013494
• MDR Text Key: 223590742
• Report Number: 3004721439-2020-00253
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20042263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2019
• 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: 7 YR
• Patient Weight: 30