MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV413T
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, visible deposits in the inlet spout and a deformation of the progav outer housing were determined.Permeability test: a permeability test has shown that all components are 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 valves are tested in both the horizontal as well as the vertical positions.The results show that the progav operates within the permissible tolerance in the horizontal position.The shuntassistant operates not within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant could be determined.Adjustment test: the progav 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 visible in both valves.Results: based on our investigation results, we can determine an accelerated outflow in the shuntassistant.The determined deposits can be named as the cause for the accelerated outflow.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known inherent side effects in hydrocephalus therapy.Furthermore, a deformation of the progav housing was detected.The deformation did not affect the technical properties at the time of the investigation.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.
Event or Problem Description
It was reported that a progav shuntsystem (#fv413t) was implanted.According to the complainant, the shunt system caused an underdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV WITH SHUNTASSISTANT 20
• 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: 21157241
• Report Number: 3004721439-2024-00422
• Device Sequence Number: 7631511
• Product Code: JXG
• UDI-Device Identifier: 04041906132101
• UDI-Public: 4041906132101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• 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): 01/15/2025

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 Expiration Date: 07/03/2016
• Device Model Number: FV413T
• Device Catalogue Number: FV413T
• Device Lot Number: 20014272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2011
• 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: 14 YR
• Patient Sex: Male
• Patient Weight: 42 KG