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

Model Number	FX214T
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported that a gav 2.0 (#fx214t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient was brought back for other unspecified complications.Additional information was received which indicated that the complications were unrelated to the shunt treatment.However, the physician believed additional drainage was needed, and planned to swap the device with a programmable valve.During the revision surgery, when the shunt was checked it did not "move the manometer with distal catheter still in place." however, the manometer drained at a normal rate after the valve was removed with just the distal catheter in place (still in the abdomen).The device was replaced with another manufacturer's device.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).

• 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
• MDR Report Key: 16995560
• Report Number: 2916714-2023-00060
• Device Sequence Number: 7067574
• Product Code: JXG
• UDI-Device Identifier: 04041906500047
• UDI-Public: 4041906500047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2023
• Report Date (Section F): 05/24/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/24/2023