MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 25 & CONTROL RESERV.; HYDROCHEPHALUS MANAGEMENT

Model Number	FX667T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (# fx667t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.(b)(6).
Additional Manufacturer Narrative
Visual inspection: during the investigation, deposits on the shunt assistant 2.0 were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over-drainage, 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 shunt assistant 2.0 operates within the specified tolerances in all positions.A slower 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 in the progav 2.0.Results: based on our investigation results, we can determine a slower outflow and adjustment difficulties in the progav 2.0.The determined deposits can be named as the cause for the slower outflow.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.Furthermore, we cannot determine functional deviations or other abnormalities in the shunt assistant 2.0.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 W/SA2.0 25 & CONTROL RESERV.
• Common Device Name: HYDROCHEPHALUS 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: 19489180
• Report Number: 3004721439-2024-00148
• Device Sequence Number: 12553916
• Product Code: JXG
• UDI-Device Identifier: 04041906503116
• UDI-Public: 4041906503116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 06/07/2024

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 Model Number: FX667T
• Device Catalogue Number: FX667T
• Device Lot Number: 20057797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG