MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX471T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: no abnormalities detected.Connected with rm 4260_1 (m.Blue).Permeability test: the test showed that the progav 2.0 is permeable.Computer control test: 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 8.33 cmh2o.This is within the specified tolerance of 8 cmh2o ± 3 cmh2o.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: in order to verify whether the investigated valve 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 valve is finally opened with a special tool.After dismantling of the valve, deposits were found in progav 2.0.Results: we are obliged to inform you that the condition of the product could be affected due to the interval between the explantation date and the receipt of the product, because fungus and mold can develop.For the sake of thoroughness and transparency, we would like to point out that an adjustment test and permeability test were already carried out after the revision at the hospital.Based on our investigation results, we can determine deposits.The deposits had no effect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.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 valve 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 (part # fx471t) was implanted during a procedure performed in 2016.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Same event as medwatch-no.: 3004721439-2022-00118 and 3004721439-2022-00119.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE 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: 15112437
• Report Number: 3004721439-2022-00212
• Device Sequence Number: 20302019
• Product Code: JXG
• UDI-Device Identifier: 04041906138165
• UDI-Public: 4041906138165
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 06/07/2023
• Device Model Number: FX471T
• Device Catalogue Number: FX471T
• Device Lot Number: 20038261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2018
• 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: 10 YR
• Patient Sex: Male