MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX802T

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

Patient Problem Hydrocephalus (3272)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that a m.Blue (#fx802t) was implanted during a procedure performed.According to the complainant, the valve is not able to be reprogrammed externally.The membrane of the valve seems to be stuck in the pressed position.The hump of the valve cannot be felt, nor can it be heard or felt to click.The valve does not change its resistance when it is tried to be reprogrammed.Based on x-rays and programming tools, and the fact that the patient has no adverse effects, the clinic is confident that the valve is implanted correctly.The patient undergoes a revision procedure.The complained device will be returned to the manufacturer for evaluation.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

The sample was returned to the manufacturer for evaluation.

Manufacturer Narrative

Investigation: visual inspection during the investigation, scratches on the outer housing of the valve, but no significant deformation or damage was determined.Permeability test: a permeability test has indicated that the valve has a blockage.Computer control test because the valve is not permeable, a computer control test is not applicable.Adjustment test the m.Blue was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational.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 the m.Blue.Result : based on our investigation results, we can determine a blockage and a non- adjustability at the valve.The determined deposits can be named as the cause for the functional deviations.Ortganic deposits in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 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: 17975882
• MDR Text Key: 326156790
• Report Number: 3004721439-2023-00310
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504410
• UDI-Public: 4041906504410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX802T
• Device Catalogue Number: FX802T
• Device Lot Number: 20062188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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: 8 MO
• Patient Sex: Male
• Patient Weight: 8 KG