MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX214T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
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 gav 2.0 valve 10/25 (fx214t) was implanted during a procedure.According to the complainant, the valve was believed to be blocked.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.No patient data were submitted.
Additional Manufacturer Narrative
An investigation was not possible, because no product was return for investigation.Based on the product documentation, we can exclude a defect at the time of delivery of the gav 2.0, our traceability indicates that the valve 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.Adjustment difficulties are not possible, due to the fact that the complained product is a fixed pressure valve.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.
Event or Problem Description
No sample returned for investigation.

• Brand Name: GAV 2.0 VALVE 10/25
• 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: 17949672
• Report Number: 3004721439-2023-00293
• Device Sequence Number: 12644857
• Product Code: JXG
• UDI-Device Identifier: 04041906500047
• UDI-Public: 4041906500047
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/14/2023

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: FX214T
• Device Catalogue Number: FX214T
• Device Lot Number: 20063522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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