MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SYS M.PAD.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX817T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a m.Blue shuntsystem was implanted.According to the complainant, the valve is reported to have shown blockage during the use.The patient underwent a revision procedure.
Additional Manufacturer Narrative
New information: a2,a4,d6 investigation: visual inspection: the following observations were made during the visual inspection: -deposits in the delivery liquid and on the outer housing permeability test: the test showed that the m.Blue is permeable.Adjustability test: we have investigated whether the m.Blue can be successfully set to each specified pressure setting of the gravitational unit.This indicating whether the valve is fully adjustable within the full range of specified pressure settings (in increments of 4 cmh2o).The m.Blue gravitational unit was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the m.Blue was within the specified tolerance and the brake function operated as expected.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, we have dismantled the valve.After dismantling of the valve, some deposits were found in the m.Blue.Results: based on our investigation, we are unable to substantiate the clinical claim of "blockage".However, we assume that the 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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: M.BLUE 10 SYS M.PAD.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11616230
• Report Number: 3004721439-2021-00063
• Device Sequence Number: 3099800
• Product Code: JXG
• UDI-Device Identifier: 04041906504533
• UDI-Public: 4041906504533
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 10/21/2024
• Device Model Number: FX817T
• Device Catalogue Number: FX817T
• Device Lot Number: 20044563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 15