MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS PROGAV 2.0 & PED.SPRUNG RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX987T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa shuntsystem mit progav 2.0 (#f987t) was implanted during a procedure performed on unknown.According to the complainant, the shunt showed an over-drainage.The patient underwent a revision procedure performed on unknown.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 1 year.Weight: 9.9 kilograms.Height: 79 centimeters.Gender: male.
Additional Manufacturer Narrative
Visual inspection: during the visual inspection a deformation of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism could confirm that with a value of -0,038 mm - outside tolerance (0 ± 0.02 mm).No other obvious damage to the valves was found.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 is operating within the accepted tolerance in the horizontal position but the prosa is operating not within the specified tolerances in the vertical position.An accelerated outflow of prosa could be determined.Adjustment test both valves were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational to both valves, the braking force of the progav 2.0 is within the given tolerances but not of the prosa.Internal inspection: after dismantling of the valves, deposits were found inside both valves.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine, at the time of our investigation, an accelerated outflow as well as a deformation on the housing surface of the prosa.The cause of the accelerated outflow could be the deposits found and for the deformation an excessive pressure exerted by the adjustment instrument.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROSA SYS PROGAV 2.0 & PED.SPRUNG RES.
• 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: 17731525
• Report Number: 3004721439-2023-00248
• Device Sequence Number: 6440778
• Product Code: JXG
• UDI-Device Identifier: 04041906142292
• UDI-Public: 4041906142292
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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: FX987T
• Device Catalogue Number: FX987T
• Device Lot Number: 20059357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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 Age: 12 MO
• Patient Sex: Male
• Patient Weight: 10 KG