MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & SPRUNG RESERVOIR; HYDROCHEPHALUS MANAGEMENT

Model Number	FX385T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx385t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, approximately two (2) days after being implanted, the valve setting was not able to be reprogrammed.The surgeon made several unsuccessful attempts to perform the adjustment with the sales representative present.The patient underwent a revision procedure.The complaint device has not yet been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: information about the complaint: information about the complaint are: "malfunction" 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 on march 2022.Deviations during assembly did not occur.The product was finally tested as article fx385t 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 2.0 has a fixed pressure of 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 a fixed pressure of 20 cmh2o, and were found to meet range the tolerances.Conclusion information: an investigation was not possible because no product was sent for investigation.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the progav 2.0 shuntsystem, since this documentation indicates that the valve is in perfect condition.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.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.Further actions: from our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & SPRUNG RESERVOIR
• Common Device Name: HYDROCHEPHALUS 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: 16507353
• Report Number: 3004721439-2023-00049
• Device Sequence Number: 19671389
• Product Code: JXG
• UDI-Device Identifier: 04041906502461
• UDI-Public: 4041906502461
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: FX385T
• Device Catalogue Number: FX385T
• Device Lot Number: 20058121
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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