MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number	FX649T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsytsem (part # fx643t) was implanted during a procedure performed in (b)(6) 2021.According to the complainant, the shunt system was believed to be operated in overdrainage and difficult to adjust.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: 2 years.Height: 100 centimeters (cm).Weight: 13 kilograms (kg).Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: third-party catheter is closed by ligature.Permeability test: the test showed that both valves are permeable.Computer control test: the computer controlled test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0,37 cmh2o.This is not within the specified tolerance of 5 cmh2o ± 3 cmh2o.An applied pressure of 5 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 5 cmh2o ± 3 cmh2o.According to our results, we can detect a presence of an accelerated outflow.Additionally, the shuntassistant 2.0 was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 25 cmh2o in the vertical position, a pressure of 25 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant 2.0 had a pressure of 23,54 cmh2o.This is within the specified tolerance of 25 cmh2o +4/-2 cmh2o.Adjustability test: the progav 2.0 was found to be not adjustable to specifications.The shuntassistant 2.0 is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated valves were 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 are finally opened with a special tool.After dismantling of the valves, deposits were found in both valves.Results: for the sake of thoroughness and transparency, we would like to point out that an adjustment test and permeability test were already carried out after the revision at the hospital.Based on our investigation results, we have determined that there was an accelerated outflow and a non-adjustability in the progav 2.0 valve at the time of our investigation.Detected deposits were the cause of the functional deviation.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 valve / 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 WITH SHUNTASSISTANT 2.0 25
• 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: 14519594
• Report Number: 3004721439-2022-00143
• Device Sequence Number: 14828181
• Product Code: JXG
• UDI-Device Identifier: 04041906502072
• UDI-Public: 4041906502072
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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 Expiration Date: 05/13/2025
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20047822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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: 2 YR
• Patient Sex: Male
• Patient Weight: 13 KG