MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROLRESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV049T
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 control reservoir (#fx049-t) was implanted together with a progav 2.0 shuntsystem (#fx420t) on (b)(6) 2023.According to the complainant, the complete shunt system with reservoir caused an under-drainage.The reservoir and the shunt system were 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 3004721439-2024-00375.
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 control reservoir with distal catheter, 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 system if aggregated in the reservoir.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 3004721439-2024-00375.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the reservoir was determined.Permeability test: a permeability test has shown that all components are permeable.Internal inspection: after coloring deposits were found.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 cannot determine functional deviations or other abnormalities in the product.The malfunction that is the cause of the complaint may be due to another product (rm 5341) included in the return.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
The device has now been sent in and could be investigated by us.Same incident as medwatch 3004721439-2024-00375.

• Brand Name: CONTROLRESERVOIR SET W/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: 20877634
• Report Number: 3004721439-2024-00376
• Device Sequence Number: 7832019
• Product Code: JXG
• UDI-Device Identifier: 04041906131487
• UDI-Public: 4041906131487
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• 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: FV049T
• Device Catalogue Number: FV049T
• Device Lot Number: 20057107
• 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: 01/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Unknown