MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX801T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue (#fx801t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system showed an under-drainage.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: 7 years, weight: 45 kgs, height: 114 cm, gender: female.
Additional Manufacturer Narrative
Visual inspection: during the investigation, bloody residue on the device was determined.Permeability test: a permeability test has shown that all components are permeable.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 vertical/ or both the horizontal as well as the vertical positions.The results show that the m.Blue operates within the accepted tolerance in both positions.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 m.Blue.Results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.Based on our investigation results, we cannot identify any functional deviations or other abnormalities in the product.At the time of the investigation, we are unable to determine how the aforementioned functional impairment occurred.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 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: 18763388
• Report Number: 3004721439-2024-00038
• Device Sequence Number: 7906892
• Product Code: JXG
• UDI-Device Identifier: 04041906504403
• UDI-Public: 4041906504403
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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 Model Number: FX801T
• Device Catalogue Number: FX801T
• Device Lot Number: 20065480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 45 KG