MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 30; HYDROCEPHALUS MANAGEMENT

Model Number	FV415T
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 shuntsystem (#fv415t) was implanted during a procedure performed on unknown date.According to the complainant, the shunt showed an under-drainage and adjustment difficulties.The patient underwent a revision procedure.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 4 years.Weight: 13 kilograms (kg).Height: 100 centimeters (cm).Gender: female.
Additional Manufacturer Narrative
Visual inspection: during the visual inspection a deformation of the outer housing of the progav could be determined.The measurement of the plane parallelism could confirm that with a value of -0,030 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has indicated that the progav is permeable while the shuntassistant has a blockage.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 is operating not within the accepted tolerance in the horizontal position.Accelerated outflow was determined during our measurement.Due to the non-permeability of the shuntsassistant, a measurement on the test bench could not be performed.Adjustment test: the progav was tested and is not adjustable.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 non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine, at the time of our investigation, accelerated outflow on the progav, a blockage on the shuntassistant, and deposits on both valves.The cause for the malfunctions mentioned could be the deposits found.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 30
• 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: 17147351
• Report Number: 3004721439-2023-00175
• Device Sequence Number: 14889133
• Product Code: JXG
• UDI-Device Identifier: 04041906132125
• UDI-Public: 4041906132125
• 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): 06/16/2023

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: 01/22/2025
• Device Model Number: FV415T
• Device Catalogue Number: FV415T
• Device Lot Number: 20045718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 13 KG