MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX431T
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 to aesculap inc.That a progav 2.0 system with control reservoir (part # fx431t) was implanted on an unspecified date.According to the complainant the device partial occlusion due to extremely high csf protein count per the surgeon.The patient underwent a revision surgery on (b)(6) 2023.No patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product investigation is restricted to tracability of manufacturing and quality control data.The progav 2.0 shunt system was manufactured by a qualified employee in (b)(6) 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.
Event or Problem Description
Investigation complete.

• Brand Name: PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 17327741
• Report Number: 2916714-2023-00081
• Device Sequence Number: 6658623
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 07/14/2023

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: FX431T
• Device Catalogue Number: FX431T
• Device Lot Number: 20059472
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/22/2023
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/02/2023
• 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: 07/14/2023