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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 25 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 25 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV442T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative
Height: 150cm. Investigation: visual inspection: in the first step of our investigations a visual inspection is performed. It is tested whether any defects, deformations or other abnormalities are to be detected. Permeability test: to proof the penetrability of the valves we have carried out a penetrability test. This test is carried out at a hydrostatic pressure of approximately of 30 cmh2o + opening pressure of each valve in the horizontal flow direction. Computer controlled test: the test is performed with a miethke computer controlled testing apparatus. The valves were tested by simulating a cerebrospinal fluid flow at rates between 60 ml/h down to 5 ml/h in the horizontal and vertical position (in acc. To iso 7197). Distilled water is used as test-liquid. Adjustment test: the adjustment test is used to examine whether progav valve can be adjusted in all pressure levels. The attempt is made to move the valves up and down in steps of 5cmh2o in the corresponding pressure range. Braking force and brake function test: to measure the braking force, we tested the progav valve with a braking force apparatus. Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus. Results: first, we performed a visual inspection of the progav shunt system the optical inspection showed no apparent defects in the product sent in. In the next step, the progav shunt system could be tested positively for permeability. In order to investigate the suspicion of an underdrainage, we carried out a computer controlled measurement on the shunt system. The valves passed the standard test in horizontal and vertical body positions. The progav valve was measured at an opening pressure of 10 cmh2o. The measurement showed that the valve operates outside the accepted tolerance. The valve shows an underdrainage. The shunt assistant was measured at an opening pressure of 25 cmh2o. The measurement showed that the valve operates inside the accepted tolerance. Additionally, we tested the adjustability as well as the brake functionality and brake force of the of the progav valve. The valve was adjustable to all settings. In addition, the brake functionality was within the accepted tolerances. However, the measurement of the braking force showed that the valve is slightly out of tolerance, with a value of 320g. Finally, we have dismantled the valves. Inside the valves, we have found small amounts of deposits (likely protein). Based on our examination results, we can confirm the suspicion of "underdrainage" for the progav-valve. The shunt assistant works within the permissible tolerances. We suspect that the deposits found inside the valves may have caused the functional impairment. Even small amounts of deposits could endanger the integrity of the valves. 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).
 
Event Description
It was reported that there is an issue with the valve. The reporter indicated that a 9 year 6 month post-operative valve is under draining. The device was explanted. Additional event details are not available.
 
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Brand NamePROGAV SYS PED.W/SA 25 A.PRECHAMBER
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9982488
MDR Text Key188557939
Report Number3004721439-2020-00078
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2015
Device Model NumberFV442T
Device Catalogue NumberFV442T
Device Lot Number20010738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2010
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: 04/21/2020 Patient Sequence Number: 1
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