MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA15 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX433T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to test the valve, the opening pressure of the valve is measured using a computer-controlled miethke test device that simulates the flow of cerebrospinal fluid.The valve is tested in the horizontal position.The results show that the valve operates within the accepted tolerances in the horizontal position.Adjustment test: the progav 2.0 was tested and is not adjustable.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.Internal inspection: after dismantling of the valve, deposits were found inside.Result based on our test results, we can determine an accelerated outflow and a non-adjustability at the valve.The deposits visible in the valve have led to the functional impairments.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.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.
Event or Problem Description
It was reported that a progav 2.0 (#fx433t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the valve showed adjustment difficulties.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: 6 years, 7 months.Weight: 17.4.Height: 111 cm.Gender: female.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.CONTROL RESERV.
• 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: 20225384
• Report Number: 3004721439-2024-00284
• Device Sequence Number: 7240114
• Product Code: JXG
• UDI-Device Identifier: 04041906137311
• UDI-Public: 4041906137311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• 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): 09/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: FX433T
• Device Catalogue Number: FX433T
• Device Lot Number: 20070359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 17 KG