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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX991T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/13/2020
Event Type  Injury  
Manufacturer Narrative
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 the prosa and progav 2. 0 valve can be adjusted in all pressure levels. The attempt is made to move the valves up and down in steps of 4 cmh2o (prosa) and steps of 5 cmh2o (progav 2. 0) in the corresponding pressure range. Braking force and brake function test: to measure the braking force, we tested the progav 2. 0 and prosa 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 prosa shunt system with progav 2. 0 adjustment unit. The optical inspection showed clear scratches on both valves, as well as a notch on the housing surface on the progav 2. 0 (proximal). As part of the optical inspection, no apparent deformation could be found on the prosa valve. However, by measuring the plane parallelism, a deformation on the housing was detected. With a value of -0,0630 mm, the prosa valve is clearly outside the permissible tolerance (tolerance 0,00 mm ± 0,02 mm). In the next step both valves and as well the control reservoir 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 prosa valve was measured at an opening pressure of 40 cmh20 in a vertical position. Two measurements were made. Both measurements resulted in an underdrainage. The progav 2. 0 valve was measured at an opening pressure of 5 cmh2o in a horizontal position. 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 prosa and progav 2. 0 valve. Both valves were adjustable to all settings. In addition, the brake force and the brake functionality were within the accepted tolerances. Finally, we have dismantled the valves. Inside the valves, we have found visible build-up of substances (likely protein). Based on our investigation, we are unable to substantiate the claim of occlusion. At the time of our investigation, the prosa shunt system was shown to be permeable. The progav 2. 0 valve also met all test criteria. However, we suspect that the deposits found inside the valve could have affected the function in the past. However, we can confirm the suspicion of an "underdrainage" for the prosa valve. We suspect that the deposits found inside the valve as well as the deformation of the housing membrane could have led to the functional impairment. 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 valve. The reporter indicated that a 7 month 16 day post-operative valve has a blockage and is under draining. The device was explanted. Additional event details are not available.
 
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Brand NamePROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
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 Key9913206
MDR Text Key188562261
Report Number3004721439-2020-00076
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141687
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 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX991T
Device Catalogue NumberFX991T
Device Lot Number20042281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
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: 04/01/2020 Patient Sequence Number: 1
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