MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 & SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX577T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation results, no functional deviations or other abnormalities was determined.At the time of return, the valve was set to a pressure setting of 9 cmh2o, so it was possible to adjust the valve in the clinic.The progav 2.0 valve is always preset to 5 cmh2o at the time of shipment.The shunt met all specifications.How the abovementioned functional impairment occurred is not clear to us at the time of examination.
Event or Problem Description
It was reported that it was impossible to change the pressure setting of the progav 2.0 valve (#fx577t) before implantation.The device was returned for examination to the manufacturer.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 & SPRUNG RESERVOIR
• 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: 20030540
• Report Number: 3004721439-2024-00237
• Device Sequence Number: 8601236
• Product Code: JXG
• UDI-Device Identifier: 04041906502539
• UDI-Public: 4041906502539
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190174
• 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): 08/21/2024

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: FX577T
• Device Catalogue Number: FX577T
• Device Lot Number: 20066411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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
• Patient Sex: Unknown