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

Model Number	FX438T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/30/2023
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 (#fx428t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve showed adjustment difficulties.The patient underwent a revision procedure.The complaint device will be return to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
It was reported that a progav 2.0 (#fx438t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt showed an over-drainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 years, 7 months.Weight: 14 kilograms (kg).Height: 93.5 centimeters (cm).Gender: male.
Additional Manufacturer Narrative
Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damage, deformation of the housing, deposits or other abnormalities.The following observations were made during the visual inspection: scratches on the outer housing permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the gav® 2.0 upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the progav 2.0 with the pediatric prechamber is permeable.Computer control test: to check the flow rate of the valve, the valve was 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, to be 3.97 cmh2o.This is not within the specified tolerance of 12.5 cmh2o ± 3 cmh2o.Additional testing confirms the first test result.According to our results, we can detect a presence of a slowed accelerated outflow.Adjustability test: in this step, it was investigated whether the adjustable progav 2.0 can be successfully set to each specified pressure setting.It was checked whether the valve is fully adjustable within the full range of specified pressure settings ( in increments of 5 cmh2o).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, as detailed in section 7.4, 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 is finally opened with a special tool.After dismantling of the valve, deposits were found in progav 2.0.For more detailed visibility, the proteins/deposits in progav 2.0 were coloured by using a colouring solution.[colouring solution consisting of coomassi brilliant blue r mixed with 0.6% ethanol and distilled water].Results: based on our investigation results, we have determined that there was an accelerated outflow and a non-adjustability in the valve at the time of our investigation.Detected deposits can be the cause of the malfunction 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.Further actions: from our point of view, no further regulatory actions are required.Return of product: we will return the investigated product to the sender for our own relief.

• Brand Name: PROGAV 2.0 SYS PED.WITH 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: 16838793
• Report Number: 3004721439-2023-00109
• Device Sequence Number: 20539049
• Product Code: JXG
• UDI-Device Identifier: 04041906137434
• UDI-Public: 4041906137434
• 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: 2021
• Device Explanted Year: 2023
• 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): 07/05/2023

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: 01/12/2026
• Device Model Number: FX438T
• Device Catalogue Number: FX438T
• Device Lot Number: 20051395
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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: 31 MO
• Patient Sex: Male
• Patient Weight: 14 KG