MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM SA2.0 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX603T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx603t) was implanted during a procedure.According to the complainant, the shuntassistant (part of #fx603t) caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2024.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.The incident was reported to the manufacturer late on november 13, 2024.
Additional Manufacturer Narrative
Manufacturing site evaluation: traceability of production data was performed and showed no deviation.The investigation is on-going.Should the investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no significant deformations or damage of the valves was permeability test: a permeability test has indicated that the shuntassistant 2.0 is permeable.Computer controlled test: to investigate the claim of blockage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the shuntassistant 2.0 is operating within the accepted tolerance in the horizontal position, but not within the specified tolerances in the vertical position.An accelerated outflow could be determined.Internal inspection: after dismantling of the valve, no deposits were found.Results: please note that due to the late return of explants for examination, we may not be able to provide meaningful examination results.Based on our test results, we can determine an accelerated outflow in the vertical position.The other parts of the original shunt system fx603t (progav 2.0, control reservoir) were not sent in for examination.Opening the valve allows a view of a significant part of the interior.In this part we could not detect organic deposits, that could explain the malfunction of the shunt.Nevertheless, there are areas which evade the visual inspection.In these parts, it is also possible to have organic deposits which can influence the function of the shunt.Organic material in the csf can temporarily influence the function and are known side effects in hydrocephalus therapy.In addition to the regular testing we performed a supplemental investigation with the shuntassistant 2.0.In this test, a solution was used to decompose possible organic deposits in the shunt.After decomposing possible organic deposits, we tested the shuntassistant 2.0 again with the computer test bench.The opening pressure of valve in the vertical position was within the specification.Consequently, we conclude there were organic deposits in the valve, which affected the function.Therefore, a defect of the product can be excluded.No further actions are required as a result of the complaint.

• Brand Name: PROGAV 2.0 SYSTEM SA2.0 25 A.CONTROL RESERVOIR
• 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: 20704970
• Report Number: 3004721439-2024-00370
• Device Sequence Number: 9638166
• Product Code: JXG
• UDI-Device Identifier: 04041906503239
• UDI-Public: 4041906503239
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 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 Model Number: FX603T
• Device Catalogue Number: FX603T
• Device Lot Number: 20073207
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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 Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 71 KG