MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA15 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX4198T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: no anomalies detected.Permeability test: the test showed that the progav 2.0 shunt system is non-permeable.To determine the location of the occlusion, the shunt system was dismantled and each element was tested individually for permeability.The test showed that the progav 2.0 is permeable, whereas the shuntassistant is non-permeable.Computer control test: to check the flow rate of the valves, the valves were tested on a miethke computer-controlled testing apparatus and passed the standard test.The flow of the test liquid was reduced step by step from 60 ml/h to 5 ml/h (in accordance with iso 7197).Distilled water was used as the test-liquid.The resulting pressure was measured.The computer- controlled test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 6,67 cmh2o.This is within the specified tolerance of 7 cmh2o ± 3 cmh2o.Due to the non-permeability of the shuntassistant, the computer- controlled test is not applicable.Adjustability test: the progav 2.0 was found to be non-adjustable within the specified range.The shuntassistant is a valve with a fixed pressure stage.Therefore, the adjustability test is inapplicable.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 valve is present.Due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valves are finally opened with a special tool.After dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we have determined a blockage in the shunt system as well as a non-adjustability of the progav 2.0 valve at the time of our investigation.Detected deposits could be named as the cause of the malfunctions.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms 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.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx419t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shunt system was believed to be operated in underdrainage and had adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 49 years.Height: 158 centimeters (cm).Weight: 71 kilograms (kg).Gender: male.

• Brand Name: PROGAV 2.0 WITH SA15 AND DISTAL CATHETER
• 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: 16134887
• Report Number: 3004721439-2022-00416
• Device Sequence Number: 20512692
• Product Code: JXG
• UDI-Device Identifier: 04041906136611
• UDI-Public: 4041906136611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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 Expiration Date: 03/24/2024
• Device Model Number: FX4198T
• Device Catalogue Number: FX419T
• Device Lot Number: 20041279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 71 KG