MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx420t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the system had adjustment difficulties.The patient underwent another surgery, but the system was not removed because the catheter had grown into the tissue.However, a new system was additionally implanted.No patient complications were reported as a result of the surgery procedure.The complained product was not sent to the manufacturer because it ist stll implanted.Same event as # 3004721439-2025-00205.
Additional Manufacturer Narrative
Manufacturing site evaluation: the product in question was not returned to the manufacturer as it is still implanted.

• Brand Name: PROGAV 2.0 WITH SA20 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: 22554264
• Report Number: 3004721439-2025-00206
• Device Sequence Number: 9647511
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/21/2025

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: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20074804
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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