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

Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.

Event Description

It was reported that a m.Blue plus (#fx804t) was implanted during a procedure performed on unknown.According to the complainant, the shunt system was not adjustable.The patient underwent a revision procedure performed on unknown.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

Event Description

It was reported that a m.Blue plus (#fx804t) was implanted during a procedure performed on unknown.According to the complainant, the shunt system showed adjustment difficulties.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: 5 years, 3 months.Weight: 18 kgs.Height: unknown.Gender: female.

Manufacturer Narrative

Manufacturing site evaluation: visual inspection: during the investigation, scratches and depositis on the outer housing of the valves, but no significant deformations or damage were determined permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the opening pressure we were using the miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The results show that the valves do not operate within the permissible tolerance in their respective relevant position.An accelerated outflow of both valves could be determined.Adjustment test: during the adjustment test it was determined that both valves are not adjustable in all pressure ranges.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected; however, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found insinde.To make the deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine that the outflow at both valves is not in tolerance and that both valves cannot be adjusted.The visible deposits in the valves may have led to the functional impairment.Deposits caused by substances naturally present in the patient's 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 organic material can affect the integrity of the valve.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.No further regulatory actions are required from our point of view.

• 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: 18695198
• MDR Text Key: 335250941
• Report Number: 3004721439-2024-00016
• Device Sequence Number: 1
• Product Code: JXG
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20053183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 18 KG