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

Model Number	FX440-T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion information: an investigation was not possible because the product is still implanted and therefore not available.Regarding similar complaints where we could examine the products, we could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Organic matter, blood or tissue particles.These 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 if aggregated in the valve.A final clarification of the cause what has led to non- adjustability is only possible by an examination.Due to missing information and the device still implanted (patient data, serial number, device itself), we are unable to provide a meaningful analysis.A final conclusion on the suspected non- adjustability is only possible with an examination.Actions: no further actions are required as a result of the complaint.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx440-t) was implanted.According to the complainant, the shunt system later showed adjustment difficulties.The valve ist still implanted and has not been removed.No further information regarding the product or the patient was submitted.

• Brand Name: PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER
• 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: 19373897
• Report Number: 3004721439-2024-00133
• Device Sequence Number: 7703318
• Product Code: JXG
• UDI-Device Identifier: 04041906137458
• UDI-Public: 4041906137458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX440-T
• Device Catalogue Number: FX440-T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown