MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX431T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 system (part # fx431t) was implanted during a procedure performed on an unknown date.According to the complainant, the system was believed to be clogged.The patient underwent a revision procedure on (b)(6) 2023.The complaint device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product investigation is restricted to trackability of manufacturing and quality control data.The progav 2.0 shunt system was manufactured by a qualified employee in may 2022.Deviations during assembly did not occur.The product was finally tested as article fx431t 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.All tested parameters were assessed according to specifications.Based on the delivery batch, we confirm all parameters have been inspected and approved during the manufacturing.We assure that production and quality control ensure that only products that are conform to specifications are made available in the market.Conclusion information: unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.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 deposits in the valve could be responsible for the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• 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: 17375425
• Report Number: 3004721439-2023-00199
• Device Sequence Number: 3784722
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: FX431T
• Device Catalogue Number: FX431T
• Device Lot Number: 20059472
• 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: 06/22/2023
• Initial Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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 Sex: Unknown