MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX602T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
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 have a blockage.Computer controlled test: because the valve is not permeable, a computer controlled test is not possible.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 in both valves.Results: in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the shunt system.Based on our investigation results, we can determine an occlusion of both valves and a non-adjustability of the progav 2.0.The visible deposits in the valves have led to the functional impairment.Deposits caused by substances naturally present in the patient's body, such as organic matter, 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.An examination of the detachment of the reservoir from the catheter revealed a damage of the catheter and the kink protection.Retrospectively, we are not able to determine how this damage occurred.Severe pulling or bending of the connection during surgery or high tensile forces can cause such damage or even rupture of the connection.Based on the fact that the shunt system had been implanted for 4 years and all catheters at miethke are cut by machine with a straight cut, we can rule out a defect at the time of delivery.Based on the traceability the shunt system met all quality control specifications at the time of release.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx602t) was implanted during a procedure.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.The complainant device was returned to the manufacturer for evaluation.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & CONTROL RES.
• 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: 20847359
• Report Number: 3004721439-2024-00374
• Device Sequence Number: 17103502
• Product Code: JXG
• UDI-Device Identifier: 04041906503222
• UDI-Public: 4041906503222
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/04/2024

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: 06/18/2025
• Device Model Number: FX602T
• Device Catalogue Number: FX602T
• Device Lot Number: 20048438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Sex: Unknown