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

Model Number	FX433T
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx433t) was implanted during a procedure performed on an unspecified date.According to the complainant, the connected ventricular catheter of the control reservoir slipped off.An additional surgery was required on (b)(6) 2025.No patient complications were reported as a result of the procedure.The complained device is still implanted.
Additional Manufacturer Narrative
Conclusion information: the reason for the disconnection / slipping cannot be explained from our side.The new inlet spout (part of a design change) is identical in size to the outlet spout and is identical to the old design.Additionally, the connection to the catheter is also identical to the previous spout of the reservoir.Therefore, the complained disconnection cannot be caused by the new design.The connection to the ventricular catheter is made exclusively in the surgery and must be performed by the surgeon.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.CONTROL 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: 22920981
• Report Number: 3004721439-2025-00241
• Device Sequence Number: 16049678
• 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
• 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): 08/29/2025

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: 20083273
• 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: 04/08/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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