MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV438T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information /investigation will be submitted in a supplemental report.
Event or Problem Description
It was reported that a progav ((#fv438t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system was believed to be operated in underdrainage and difficult to adjust.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: 85 cm, weight: (b)(6) kg, gender: male.
Additional Manufacturer Narrative
Investigations: visual inspection: the following observations were made during the visual inspection: turbid / non-transparent membrane.Measurement of surface of the housing: derformation detected: no - measured value: - 0.02mm [tolerance (0 ± 0.02mm)].Permeability test: the test showed that the progav with ped.Prechamber and ventricular catheter is permeable.Computer control test: the computer controlled test showed the opening pressure of the progav, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0.28 cmh2o.This is not within the specified tolerance of 9 cmh2o ± 3 cmh2o.An applied pressure of 9 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 9 cmh2o ± 9 cmh2o.Additional testing did not significantly change the results.According to our results, we determine a presence of an accelerated outflow.Adjustability test: the progav was found to be non-adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the progav is present.Due to the non-adjustability of the valve, as detailed in section 7.5, an investigation of the braking force was not possible.Internal inspection of product: after dismantling of the valve, strong deposits were found in progav.Results: based on our investigation results, we can identify a non-adjustability and an accelerated outflow at the valve.We are assuming that the deposits detected within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The valve 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 SYSTEM PED.WITH PRECHAMBER
• 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: 13177308
• Report Number: 3004721439-2021-00361
• Device Sequence Number: 4624664
• Product Code: JXG
• UDI-Device Identifier: 04041906132514
• UDI-Public: 04041906132514
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 01/14/2025
• Device Model Number: FV438T
• Device Catalogue Number: FV438T
• Device Lot Number: 20045740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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: 11 KG