MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 10 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV439T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav shuntsystem (#fv439t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be difficult to adjust.The patient underwent a revision procedure 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: 6 years.Gender: female.
Additional Manufacturer Narrative
Additional information - a4, b7, d4 (serial #), d9, e1 corrected information - b3, d6b investigation: visual inspection: the following observations were made during the visual inspection: -particles in the delivery liquid -deformation of the housing -deposits on and in the prechamber.Measurement of surface of the housing: to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.Deformation detected: yes - measured value: - 0.072 mm [tolerance (0 ± 0.02mm)] too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the test showed that the progav shunt system is permeable.Computer control test: the computer controlled test showed the opening pressure of the progav, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 1.09 cmh2o.This is within the specified tolerance of 3 cmh2o ± 3 cmh2o.Additionally, the shuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 10 cmh2o in the vertical position, a pressure of 10 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant had a pressure of 10.73 cmh2o.This is within the specified tolerance of 10 cmh2o +4/-2 cmh2o.Adjustability test: the progav was found to be adjustable to all pressure settings.The shuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force and brake function test investigates whether the brake function of the adjustable valves is present and how much force must be exerted on the housing to release the rotor to adjust the valves using the integrated magnet of a specific measurement apparatus of braking force.The braking force of the progav was not within the specified tolerance.The brake could be deactivated with a lower force on the valve.The brake function is present.Internal inspection of product.In order to verify whether the investigated shunt system were 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: in advance, we are obliged to inform you that the condition of the product could be affected due to the interval between the explantation date and therelease of the product.So the investigation result could be invalid because the time of delay of the start of the investigation.Based on our investigation results, we have determined that there was a deformation oft he progav valve housing and a lower braking force at the progav valve at the time of our investigation.The detected deformation was the cause of the brake malfunction.Additionally, the existing deposits in the valves can temporarily impair the function 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.

• Brand Name: PROGAV SYS PED.W/SA 10 A.PRECHAMBER
• 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: 14881134
• Report Number: 3004721439-2022-00201
• Device Sequence Number: 12302665
• Product Code: JXG
• UDI-Device Identifier: 04041906132521
• UDI-Public: 4041906132521
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 09/22/2024
• Device Model Number: FV439T
• Device Catalogue Number: FV439T
• Device Lot Number: 20043983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 48 KG