MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA10 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX350T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964); Thickening of Material (4056)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -some organic particles in the delivery liquid; -loosened lid of progav 2.0; -deposits on the brake spring/rotor are visible based on the photo of the clinic; -the components of the progav 2.0 are separated from the valve and individually; -deposits on the spring; -deposits in the perforation of ventricular catheter (perforation blocked).Permeability test: due to the loosened lid, the permeability at the shunt system was not able to be performed anymore.The test of the sprung reservoir connected with the ventricular catheter showed a blockage.The disconnected shunt assistant showed that was permeable.Computer control test: the computer control test could be performed only on the shunt assistant.Due to the loosened lid, the test is not applicable to the progav 2.0.The computer control test showed the opening pressure of the shunt assistant, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 14.90 cmh2o.This is not within the specified tolerance of 10 cmh2o +4/-2 cmh2o.An applied pressure of 10 cmh2o, with the device in the vertical position is expected to have a resultant pressure of 10 cmh2o +4/-2 cmh2o.According to our results, we can detect a presence of a slowed outflow.Adjustability test: the adjustment test is also not applicable to the progav 2.0 due to the loosened lid.The shunt assistant is a fixed pressure valve, therefore the adjustability test is also inapplicable.Braking force and brake function test: likewise, the test before, the test would only be applicable with the lid closed.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valves is finally opened with a special tool.After dismantling of the valve, deposits were found in shunt assistant.The dismantling of the progav 2.0 is not required, because the lid was already loosened.For more detailed visibility, the proteins/deposits in the shunt assistant were coloured by using a colouring solution.Results: based on our investigation results, we have determined that there was a blockage in the ventricular catheter and a slower outflow in the shunt assistant at the time of our investigation.Detected deposits were the cause of the blockage and slower outflow in the shunt system.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.The progav 2.0 was submitted to us open with a loosened lid.A clear explanation under which circumstances the lid got lost have not been submitted.To exclude that there might be a deviation in the performance of the valve we investigated the valve very carefully.First it was detectable that some damages on the surface of the lid edges and on the opposite side of the valve housing (see picture 14) are present.These damages have not been made during assembling of the valve or during inspection activities in the clean room of our facility.The presence of these damages remains unclear.Then we investigated if an unintended loose of the lid might be possible.After reassembling the lid to the valve housing, we checked if the resistance against over pressure is still given.We increased the pressure inside the valve up to 5 bar and the lid remains stable.Finally, we assessed that the loose of the lid is just possible under extreme circumstances which cannot occur under normal implanted conditions as well as under normal expectable explantation circumstances.We assessed that the valve is inside all declared manufacturers specification.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx350t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operated in underdrainage and difficult to adjust.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: 7 years.Height: 119.5 centimeters (cm).Weight: 19.1 kilograms (kg).Gender: female.

• Brand Name: PROGAV 2.0 WITH SA10 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: 16742789
• Report Number: 3004721439-2023-00089
• Device Sequence Number: 14811292
• Product Code: JXG
• UDI-Device Identifier: 04041906139995
• UDI-Public: 4041906139995
• 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 Explanted Year: 2023
• 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): 04/14/2023

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 Model Number: FX350T
• Device Catalogue Number: FX350T
• Device Lot Number: 20058835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: 7 YR
• Patient Sex: Female
• Patient Weight: 19 KG