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

Model Number	FX802T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue plus (#fx802t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt showed a fault after implantation.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional 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 or Problem Description
It was reported that a m.Blue plus (#fx802t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the valve showed an under-drainge.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 3 years, 3 months weight: 16 kgs height: 97 cm gender: male.
Additional Manufacturer Narrative
Additional information: a2 (patient age), a3 (patient sex), a4 (patient weight), b3 (date of event), b5 (event updated with additional information), b7 (relevant history), d4 (serial number, lot number, expiration date), d6a (implatation date), h4 (manufacture date) corrected information: b3(date of event), b5 (revision date updated) visual inspection: during the investigation, no significant deformations or damage of the valve was determined.Permeability test: a permeability test has shown that the m.Blue is permeable.During the permeability test bloody liquid were flushed out.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the m.Blue operates within the accepted tolerance in either position.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, no deposits were found in the m.Blue to make the deposits in the valve more visible, they were colored using a staining solution.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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
• 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: 18336157
• Report Number: 3004721439-2023-00372
• Device Sequence Number: 18248908
• Product Code: JXG
• UDI-Device Identifier: 04041906504410
• UDI-Public: 4041906504410
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: 3 YR
• Patient Sex: Male
• Patient Weight: 16 KG