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

Model Number	FX812T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: scratches on the m.Blue housing.Colored peritoneal catheter.Peritoneal catheter connected a piece of catheter with a third- party connector.Permeability test: the test showed that the m.Blue and the peritoneal catheter are permeable.Computer control test: the computer control test showed the opening pressure of the differential unit of the valve, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 11.35 cmh2o.This is within the specified tolerance of 10 cmh2o ± 3 cmh2o.Additionally, the gravitational unit of the valve was tested according to standard procedure in the vertical position of the valve.At an opening pressure of 16 cmh2o in the vertical position, a pressure of 16 +6/ -12 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the gravitational unit of the m.Blue had a pressure of 13.50 cmh2o.This is within the specified tolerance of 16 +6/ -12 cmh2o.Adjustability test: the m.Blue was found to be not adjustable to specifications.Braking force and brake function test: the braking force test indicates that the brake function of the m.Blue is present.Due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated valve 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, the valve is finally opened with a special tool.After dismantling of the valves, deposits were found in m.Blue.Results: based on our investigation results, we have determined that there was a non- adjustability of the valve at the time of our investigation.Detected deposits were the cause of the non- adjustability.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.We can exclude a defect at the time of release.The valve system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
Event or Problem Description
It was reported that a m.Blue (part # fx812t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve was believed to be difficult to adjust and operate in over-drainage.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 72 years.Height: 170 centimeters (cm).Weight: 65 kilograms (kg).Gender: female.

• Brand Name: M.BLUE 10 SHUNT SYSTEM
• 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: 15990196
• Report Number: 3004721439-2022-00384
• Device Sequence Number: 6208852
• Product Code: JXG
• UDI-Device Identifier: 04041906504496
• UDI-Public: 4041906504496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 09/21/2025
• Device Model Number: FX812T
• Device Catalogue Number: FX812T
• Device Lot Number: 20049875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG