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U.S. Department of Health and Human Services

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

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV438T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/18/2020
Event Type  Injury  
Manufacturer Narrative
Investigation is completed: opening pressure upon intake at the time of intake, the progav showed a pressure setting of 1 cmh2o. Visual inspection: the following observations were made during the visual inspection: deformation of the housing. 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. The measurement of the plane parallelism confirmed the observations of the optical inspection. The measured value of -0,023 mm lies not within the given tolerance (0 ± 0. 02mm). Permeability test: the test showed that the progav is permeable. Computer controlled test in order to investigate the suspicion of over-drainage, the progav was tested on a miethke computer controlled testing apparatus. The valve was tested by simulating a cerebrospinal fluid flow at rates from 60 ml/hr down to 5 ml/hr with the valve in horizontal position (in accordance with iso 7197). Distilled water was used as the test-liquid. The resulting opening pressure was measured. The computer controlled test has shown the opening pressure of the progav, at a reference flow rate of 20 ml/hr in a horizontal position, to be 0,90 cmh2o. This is within the specified tolerance of 1 cmh2o ± 3 cmh2o. An applied pressure of 1 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 1 cmh2o ± 3 cmh2o. Adjustability test: the progav was adjustable to all pressure setting. Braking force and brake function test: the braking force of the progav was not within the specified tolerance and the brake function operated as expected. This malfunction could be due to the deformation of the housing surface. 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, we have dismantled the valve. After dismantling of the valve, clearly deposits were found in the progav. Results based on our investigation, we are not able to substantiate the claim of "over-drainage"" however, we assume that the significant deposits found within the valve may have temporarily caused the functional impairment. Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of 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 (b)(4). From our point of view, no further regualatory actions are required.
 
Event Description
It was reported that there was a problem with a progav valve. The problem - adjustment inability of a programmable element (inability to reset the shunt pressure). Patient information: age: (b)(6) year. Weight: (b)(6) kg. Height: 120 centimeters. Implantation: (b)(6) 2018. Removal: (b)(6) 2020.
 
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Brand NamePROGAV SYSTEM PED.WITH PRECHAMBER
Type of DeviceHYDROCEPHALUS 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 Key10235566
MDR Text Key197760770
Report Number3004721439-2020-00137
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV438T
Device Catalogue NumberFV438T
Device Lot Number20033479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/06/2020 Patient Sequence Number: 1
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