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

Model Number	FX417T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a problem with an implanted progav 2.0 (fx417t).Description of the problem: the feature of this product is that the lock mechanism works up to 3 tesla by mri lock, and the pressure does not change.However, the pressure of the implant in the patient changes every time an mri is performed.No sample (product data) available.
Additional Manufacturer Narrative
Manufacturing and quality control data: no manufacturer data are available, because no product data were submitted.Probably the product was finally tested as article fx417t and released for packaging and sterilization and was sterilized by miethke.Apart from the article number, we have no further traceability data (because missing product data).The progav 2.0 has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o.The valves are preset to 5 cmh2o in accordance with the specification.Reason of complaint: "the feature of this product is that the lock mechanism works up to 3 tesla by mri lock, and the pressure does not change.However, the pressure of the implant in the patient changes every time an mri is performed." result: an investigation was not possible because the product is not available.With reference to the reason for the complaint, we would like to point out that the "active-lock" mechanism of the progav 2.0 prevents unintentional valve adjustments due to external magnetic fields (up to 3 tesla).The valves have been validated according to the mentioned specifications and maintain this standard.However, the valve specifications can be influenced by deposits within the valve.Due to missing sample, we are unable to provide a meaningful analysis.Based on the current information, no further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH 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: 12908979
• Report Number: 3004721439-2021-00318
• Device Sequence Number: 4956180
• Product Code: JXG
• UDI-Device Identifier: 04041906136598
• UDI-Public: 4041906136598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX417T
• Device Catalogue Number: FX417T
• 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: 11/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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