MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.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 shuntsystem (#fx420t) was implanted together with a controlreservoir (#fx049-t) on (b)(6) 2023.According to the complainant, the shunt system caused an under-drainage.The shunt tube was removed.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.*same incident as medwatch 3004721439-2024-00376.
Additional Manufacturer Narrative
Due to the limited information and the missing product investigation is restricted to traceability of manufacturing and quality control data.Based on the product documentation, we can exclude a defect at the time of delivery of the progav 2.0 shunt system, our traceability indicates that the device was in perfect condition.Regarding similar complaints where we could examine the products, we could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These 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 if aggregated in the valve.A final clarification of the cause what has led to "blockage" is only possible by an examination.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.
Event or Problem Description
No sample available for examination.*same incident as medwatch 3004721439-2024-00376.
Additional Manufacturer Narrative
Changes made in this report: d4 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.During the permeability test bloody liquid was flushed out.Computer controlled test: to investigate the claim of under-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 valves operate within the permissible tolerance in their respective relevant positions.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: the case being processed here had to be reopened, as it was originally reported that no product would be sent in and the case was therefore already completed.Following a delay, the sample was sent to us after all.We assessed the sample and decided to carry out the investigation.Based on our investigation results, we can determine adjustment difficulties in the progav 2.0.The determined deposits can be named as the cause for the functional deviation.Organic material in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.Furthermore we can determine deposits in the shuntassistant.The deposits had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the 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.
Event or Problem Description
The device has now been sent in and could be investigated by us.Same incident as medwatch 3004721439-2024-00376.

• Brand Name: PROGAV 2.0 WITH SA20 AND DISTAL CATHETER
• 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: 20877622
• Report Number: 3004721439-2024-00375
• Device Sequence Number: 7683605
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/15/2025

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 Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20056713
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/06/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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: 10 YR
• Patient Sex: Unknown