MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 30; HYDROCEPHALUS MANAGEMENT

Model Number FV415T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Event Description

It was reported that a progav shuntsystem (#fv415t) was implanted during a procedure.According to the complainant, the shunt system caused an underdrainage and 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: 4 years.Height: 110 cm.Weight: 16 kg.Gender: male.

Manufacturer Narrative

Investigation: visual inspection: during the investigation, visible deposits in the outlet spout of the shuntassistant were determined.No significant deformations or damage of the outer housing of the progav was visible, but the measurement of the plane parallelism has revealed with a value of -0.058 mm [outside the tolerance of 0 ± 0.02 mm] a deformation.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of under-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 does not operate within the accepted tolerance in the horizontal position.The shunt assistant 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 of the progav.The determined deposits and the deformation can be named as the cause for the functional deviation.Organic deposits in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.In the shuntassistant, we can 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 WITH SHUNTASSISTANT 30
• Type of Device: 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: 18731606
• MDR Text Key: 335719817
• Report Number: 3004721439-2024-00030
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Model Number: FV415T
• Device Catalogue Number: FV415T
• Device Lot Number: 20063841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 16 KG