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

Model Number	FV413T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav shunt system (part # fv413t) was implanted during a procedure performed on an unknown date.According to the complainant, the system was believed to be operated in over-drainage and adjustment difficulties.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 13 years.Height: 160 centimeters (cm).Weight: 53 kilograms (kg).Gender: female.
Additional Manufacturer Narrative
Visual inspection: some tissue residues were found on the catheter during the optical inspection.Furthermore, no significant deformations or damages of the valve could be detected, but the measurement of the plane parallelism showed a deformation with a value of -0.067 mm [outside the tolerance of 0 ± 0.02 mm].Permeability test: a permeability test has shown that all components are permeable.During the permeability test bloody liquid were flushed out.Computer controlled test: to investigate the claim of over- 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 valves operate within the accepted tolerance in their respective positions.Adjustment test: the progav has been tested and is only adjustable to a limited extent.2.8.Braking force and brake function test the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the limited adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found inside.To make the proteins/deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our inspection results, we can determine a deformation of the housing surface of the progav® as well as a limited adjustability.The deposits found may be the reason for the malfunctions determined.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 WITH SHUNTASSISTANT 20
• Common Device Name: HYDROCHEPHALUS 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: 16482774
• Report Number: 3004721439-2023-00037
• Device Sequence Number: 18060266
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: 07/08/2015
• Device Model Number: FV413T
• Device Catalogue Number: FV413T
• Device Lot Number: 20011618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2010
• 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: 13 YR
• Patient Sex: Female
• Patient Weight: 53 KG