MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS M.SA20 U.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx434t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in underdrainage and was difficult to adjust.Reportedly, following the primary surgery, the patient showed no improvement in hydrocephalus, so pressure changes were performed several times.After that, when the doctor tried to change the pressure, the pressure could not be changed.The doctor could push the reservoir, but felt resistance.The doctor believes that the protein component may have clogged the valve.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 4 years, 3 months; gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: cut in the kink protection between the valves.Permeability test: the test showed that the progav 2.0 shunt system is permeable.Computer control test: the computer controlled test showed the opening pressure of the progav2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0.44 cmh2o.This is not within the specified tolerance of 8 cmh2o ± 3 cmh2o.An applied pressure of 8 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 8 cmh2o ± 3 cmh2o.According to our result, we can determine a presence of an accelerated outflow.Additionally, the shunt assistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 20 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shunt assistant had a pressure of 19.23 cmh2o.This is within the specified tolerance of 20 cmh2o +4/-2 cmh2o.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.The shunt assistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.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 were finally opened with a special tool.After dismantling of the valves, deposits were found in progav 2.0.In the shunt assistant were no visible deposits.Results: based on our investigation results, we have determined that there was an accelerated outflow in the progav 2.0 valve at the time of our investigation.The detected deposits could be the cause of the accelerated outflow.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms 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.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYS M.SA20 U.CONTROL RESERV.
• 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: 15464898
• Report Number: 3004721439-2022-00286
• Device Sequence Number: 6897027
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 4041906137328
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20056727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: 74 YR
• Patient Sex: Female