MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX466T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/05/2023
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 2.0 (#fx466t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complaint device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
With the return of the sample, new information was made available.It was reported that a progav 2.0 (#(b)(6)) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve caused an overdrainage and had adjustment difficulties.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.Age: 1 year, 5 months.Height: 80 centimeters (cm).Weight: 10.4 kilograms (kg).Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -particles in the pediatric prechamber -particles in the delivery liquid -deposits on the product.Permeability test: the test showed that the progav 2.0 with the pediatric prechamber is permeable.Computer control test: the computer control 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 7.64 cmh2o.This is within the specified tolerance of 7 ± 3 cmh2o.Adjustability test: the progav 2.0 was found to be non-adjustable within the specified range.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 test indicates that the brake function of the progav 2.0 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 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 was finally opened with a special tool.After dismantling of the valve, deposits were found in progav 2.0.Results: based on our investigation results, we have determined that the valve was not adjustable in the specific range at the time of our investigation.Detected deposits were the cause of the "non- adjustability".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 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.

• Brand Name: PROGAV 2.0 WITH PED.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: 17051429
• Report Number: 3004721439-2023-00162
• Device Sequence Number: 3479710
• Product Code: JXG
• UDI-Device Identifier: 04041906137502
• UDI-Public: 4041906137502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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 Model Number: FX466T
• Device Catalogue Number: FX466T
• Device Lot Number: 20059245
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: 17 MO
• Patient Sex: Male
• Patient Weight: 10 KG