MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA15 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX419T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion information: an investigation was not possible because the product is still implanted.The progav 2.0 is an adjustable differential pressure unit equipped with a tactile feedback mechanism.This mechanism allows the user to feel exactly when the pressure is sufficient for adjustment.In addition, the unique "active lock" mechanism protects the progav 2.0 from accidental adjustment due to the influence of external magnetic fields.According to our documentation, the progav 2.0 is classified as mr-conditional, see "mri safety information" on miethke website.The "active lock" can be deactivated by pressing the valve membrane.The release is indicated by a click.The valve can only be adjusted with the adjustment tool once it has been deactivated.In the case described, the doctor was able to adjust the valve without any problems and hear the click sound.The cause of the unintentional adjustment before is unknown to us.Please note: sometimes, the adjustment tool might be right next to the compass during the measurement.When checking with the progav 2.0 compass, please make sure, that there are no other magnetic sources nearby to affect the compass needle.A meaningful analysis is only possible by an examination.
Event or Problem Description
It was reported that a progav 2.0 (#fx410t) was implanted during a procedure.According to the complainant, the shunt system showed an involuntary valve pressure adjustment.Here was no blockage, there was a clicking sound when the valve was pressured and the doctor was able to adjust the pressure without any problems.No revison is scheduled at the time of the report.The valve is still implanted.

• Brand Name: PROGAV 2.0 WITH SA15 AND DISTAL CATHETER
• 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: 22773391
• Report Number: 3004721439-2025-00234
• Device Sequence Number: 9167274
• Product Code: JXG
• UDI-Device Identifier: 04041906136611
• UDI-Public: 4041906136611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2025

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: FX419T
• Device Catalogue Number: FX419T
• Device Lot Number: N/A
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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