MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX352T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx352t) was implanted during a procedure performed on (b)(6) 2025.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was not yet sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
The complained product was sent to the manufacturer and the investigation has been completed.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valve were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant could be determined.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: based on the investigation results, visible deposits were determined in the progav 2.0 and in the sprung reservoir.In addition, a cut in the membrane of the reservoir was detected.At the time of the investigation, the deposits and the cut had no influence to the product properties.The components operated within all specifications.Furthermore, an accelerated outflow of the shuntassistant was determined.The visible deposits in the valve can be identified as the cause of the functional deviation.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, 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.The suspicion of a valve damaged or defective due to a fall could not be confirmed during the investigation.The examination of the return has been completed with the drafting of this report.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH SA20 A.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: 22030196
• Report Number: 3004721439-2025-00139
• Device Sequence Number: 12827116
• Product Code: JXG
• UDI-Device Identifier: 04041906140014
• UDI-Public: 4041906140014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/05/2025

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: FX352T
• Device Catalogue Number: FX352T
• Device Lot Number: 20079023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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