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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX410T
Device Problem Mechanical Problem (1384)
Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
Patient height: (b)(6). Investigation is completed: visual inspection: we have checked for possible damages, deformations of the housing or other abnormalities. The following observations were made during the visual inspection: deposits in the outlet spout. Permeability test: this test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx. 30 cmh2o in the direction of flow. The test showed that the progav 2. 0 is permeable. Adjustability test: thus indicating 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 adjustable to all pressure settings. Braking force and brake function test: a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves. This apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus. The braking force of the progav 2. 0 was within the specified tolerance and the brake function operated as expected. After dismantling of the valve, slightly deposits were found in progav 2. 0. Based on our investigation, we are not able to substantiate the claim of "programming issues". At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred. 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. Even small amounts of non-visible deposits might compromise the integrity of the valve. 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 regulatory actions are required.
 
Event Description
It was reported that the was an issue with a prosa and progav 2. 0. "the surgeon attempted to move the prosa setting from 12 to 14 when she adjusted valve to 0. Attempted to move back to 12- 14 and valve was stuck at 0. She also believes there have been inconstant readings on progav 2. 0. " height: (b)(6). Implantation: 2017. Removal: (b)(6) 2020. "associated medwatches: 3004721439-2020-00123 , mdr # - same patient".
 
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Brand NamePROGAV 2.0 VALVE
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 Key10205891
MDR Text Key198310355
Report Number3004721439-2020-00110
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161853
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 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2021
Device Model NumberFX410T
Device Catalogue NumberFX410T
Device Lot Number20029842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2016
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: 06/29/2020 Patient Sequence Number: 1
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