MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W.PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX816T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue (part # fx816t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to be not adjustable.The patient will be reviewed again in six (6) weeks.At this review, the surgeon will decide whether the product should be explanted or not.
Additional Manufacturer Narrative
Manufacturing site evaluation: the valve is still implanted and an investigation could not be performed.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing and quality control data: the m.Blue® was manufactured by a qualified employee in december 2020.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The m.Blue® has a fixed/ normal pressure range of 5 to 45 cmh2o.The valve was inspected as article fx816t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.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.(see section 2.6).Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve is not operating within the acceptable tolerance in the horizontal and vertical position.Internal inspection: after dismantling of the valve, deposits were found in m.Blue®.Results: based on the results of our investigation, we were able to determine at the time of our investigation an accelerated outflow and adjustment difficulties at the valve.The identified deposits can be named as the cause for the functional deviations.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 5 SYS W.PED.CONTROL RESERVOIR
• 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: 15204404
• Report Number: 3004721439-2022-00231
• Device Sequence Number: 14615522
• Product Code: JXG
• UDI-Device Identifier: 04041906504526
• UDI-Public: 4041906504526
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 12/07/2025
• Device Model Number: FX816T
• Device Catalogue Number: FX816T
• Device Lot Number: 20050890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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 Sex: Male