MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FX412T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav 2.0 shunt system was manufactured by a qualified employee on(b)(6)2021.Deviations during assembly did not occur.The product was finally tested as article fx412t and released for packaging and sterilization and was sterilized by miethke.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, and were found to meet specifications.The valve was pre-adjusted to 5 cmh2o in accordance with the specification.The shuntassistant has a fixed pressure of 15 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at fixed pressure of 15 cmh2o, and were found to meet specifications.All tested parameters were assessed according to specifications.Conclusion information: an investigation was not possible because the device is still implanted.Based of the product traceability, we can exclude a defect of the progav 2.0 shuntsystem.The cause of the self- adjustability could not be determined.Our ifu describe this fact of functional safety in section "functional safety and compatibility with diagnostic procedure ".Nuclear magnetic resonance examinations up to a field strength of 3 tesla or computed tomography examinations can be performed without risk or impairment to the valve function.The valve is mr conditional.A warning is included in the ifu [if a amgnetic field is being applied and pressure is applied to the valve at the same time, it is possible to rule out valve adjustment.In mri the progav 2.0 creates artefacts which are larger than the valve itself] another or similar occurrence was not reported in the past.A detailed conclusion about the malfunction in the valve, would require an examination of the product.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx412t) was implanted during a procedure performed on (b)(6)2022.According to the complainant, the shunt system was believed change the pressure setting during a mri.This product was implanted in a patient at a set pressure of 12 centimeters water (cmh2o).After transfer, the patient suffered from another disease and when an mri scan was performed, it was confirmed that the pressure setting had been changed to around 6 cmh2o.There is no mention of pressure change in the patient's medical record, and the doctor at the facility also stated that no pressure change was made.The patient was under-drainage and the pressure setting needed to be lowered, so it did not cause any serious problems.The shuntsystem is still implanted.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 15
• 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: 15261254
• Report Number: 3004721439-2022-00242
• Device Sequence Number: 12421003
• Product Code: JXG
• UDI-Device Identifier: 04041906136543
• UDI-Public: 4041906136543
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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 Expiration Date: 04/20/2026
• Device Model Number: FX412T
• Device Catalogue Number: FX412T
• Device Lot Number: 20052785
• 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: 07/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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
• Patient Sex: Female