MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA10 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX439T
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the traceabilty of the device could be carried out.No deviation was determined based on the documentation of the control data.Further investigation will be carried out upon receipt the exact product issue and the sample for testing.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 (#fx439t) was implanted 2 yeasr ago.The description of the problem / the reason for the explantation is unclear at the time of submission the report.The reported details are inconsistent and a request to the complainant has been send regarding the product problem.The patient underwent a revision procedure.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
It was reported that a progav 2.0 (#(b)(4)) was implanted 2 years ago.The reason for the explantation is stated as adjustment difficulties.The patient underwent a revision procedure.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valve were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the valves, 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 2.0 does not operate within the accepted tolerance in the horizontal position.The paedishuntassistant operates within the specified tolerances in the both positions.An accelerated outflow of progav 2.0 could be determined.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected; however, the breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found.Results: according to the investigation results, a non-adjustability and an accelerated outflow of the progav 2.0 was detected.The visible deposits have led to the functional deviations.Furthermore, we can determine visible deposits in the paedishuntassistant.The deposits had no effect upon the specifications at the time of the examination.The valve operated within all specifications.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.The examination of the return has been completed with the drafting of this report.

• Brand Name: PROGAV 2.0 SYS PED.W/SA10 A.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: 20964897
• Report Number: 3004721439-2024-00411
• Device Sequence Number: 14461199
• Product Code: JXG
• UDI-Device Identifier: 04041906137441
• UDI-Public: 4041906137441
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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): 02/24/2025

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: 11/03/2024
• Device Model Number: FX439T
• Device Catalogue Number: FX439T
• Device Lot Number: 20044772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 13 KG