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 Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx419t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the progav 2.0 could not be adjusted.The patient underwent a revision procedure on (b)(6) 2025.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: the traceability of the production did not reveal any unusual findings.The shunt system met all specifications before shipment.The sample has not yet been sent for examination.Should relevant additional information become available, a supplemental medwatch report will be submitted.
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 the progav 2.0 is permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve operates within the permissible tolerance in the horizontal position.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected; however, the breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found inside.Results: according to the investigation results, a non-adjustability is detected.The visible deposits have led to 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 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 (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx419t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the progav 2.0 could not be adjusted and caused an under-drainage.The patient underwent a revision procedure on (b)(6) 2025.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.

• 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: 21730153
• Report Number: 3004721439-2025-00084
• Device Sequence Number: 21083150
• 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
• Device Implanted Year: 2023
• 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): 05/20/2025

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: FX419T
• Device Catalogue Number: FX419T
• Device Lot Number: 20071124
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 45 KG