MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV427T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav shuntsystem (#fv427t) was implanted during a procedure.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 54 years, height: 170 cm, weight: 80 kg, gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, some dry and bloody residue tissues on the device were determined.No deformations or damage of the outer housing of the progav could be determined, the measurement of the plane parallelism confirmed this.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the flow in the valve, 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 operates not within the accepted tolerance in the horizontal position.The shuntassistant operates within the specified tolerances in the vertical position.An accelerated outflow of progav could be determined.Adjustment test: the progav was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results : in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we can determine an accelerated outflow and adjustment difficulties in the progav.The determined deposits can be named as the cause for the functional deviation.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.In the hunt assistant we can also determine deposits.The deposits had no effect to the technical properties at the time of the investigation.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.

• Brand Name: PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
• 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: 19499992
• Report Number: 3004721439-2024-00162
• Device Sequence Number: 15137142
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 06/10/2024

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 Expiration Date: 05/06/2015
• Device Model Number: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20011187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2010
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 80 KG