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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 U.CONTROL RES. HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 U.CONTROL RES. HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX552T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
Visual inspection: in the first step of our investigations an optical control is carried out. It is checked whether any defects, deformations or other noticeable irregularities can be identified. Permeability test: to proof the penetrability of the valves we have carried out penetrability tests. These tests are carried out at a calculated hydrostatic high (open pressure of the valves + 30 cmh2o) in horizontal direction of flow. Braking force and brake function test: to measure the braking force, we tested the progav 2. 0 shuntsystem 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. Adjustment test: the adjustment test is used to ensure that the progav 2. 0 can be adjusted to all pressure levels. The tests are carried out with the standard progav 2. 0 check-mate and measurement tool. The valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o. Results: the optical inspection showed clear blood residues on the product sent in. Beyond that, however, no other obvious damage was detected. Next we tested the permeability of the valves. Both valves were shown to be permeable. In order to investigate the suspicion of underdrainage, we carried out a computer controlled measurement. The progav 2. 0 was tested at a set pressure level of 4 cmh20 (pressure level at the time of intake). The test bench measurement showed that the progav 2. 0 worked, in the reference flow range of 20 ml/h in the horizontal body position with a value of 5. 38 cmh2o, within the permissible tolerance (permissible tolerance 4 cmh2o ± 3 cmh2o). Furthermore, the shuntassistant 2. 0 passed the standard test in the vertical body position. At a fixed opening pressure of 25 cmh2o, a resulting pressure in standing body position of 23 cmh2o to 29 cmh2o would have been expected. The measurement showed that the shuntassistant 2. 0 worked, in the reference flow range of 20 ml/h in the vertical body position with a value of 10. 65 cmh2o, outside the permissible tolerance (permissible tolerance 23 cmh2o to 29 cmh2o). A second measurement was performed. The second measurement showed that the shuntassistant 2. 0 continued to operate, in the reference flow range of 20 ml/h in the vertical body position with a value of 20. 79 cmh2o, outside the permissible tolerance (permissible tolerance 23 cmh2o to 29 cmh2o), even though the values have improved significantly. The valve shows an overdrainage. Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2. 0 valve. The valve operated as expected and met all specifications. Finally, we have dismantled both valves. Inside both valves we have found slight build-up of substances (likely protein and/or blood), see pictures 1 and 2. Based on our investigation, we are unable to substantiate the claim of under-drainage, at the time of our investigation. Rather, we were able to demonstrate overdrainage with the shuntassistant 2. 0. The progav 2. 0 met all expected specifications. We suspect that the deposits found inside the valve have led to the functional impairment. We can exclude a defect at the time of release. The shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
It was reported that there was a problem with a progav 2. 0 shuntsystem. The reporter pointed out that after 11 months and 30 days, the shunt system showed signs of underdrainage. The shuntsystem was explanted. Patient information: age : (b)(6) years. Weight: (b)(6) kg. Hight: 180 cm. Gender: unknown.
 
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Brand NamePROGAV 2.0 SYS SA2.0 25 U.CONTROL RES.
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 Key10231075
MDR Text Key198310450
Report Number3004721439-2020-00127
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190174
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 Received07/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX552T
Device Catalogue NumberFX552T
Device Lot Number20041926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2019
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: 07/05/2020 Patient Sequence Number: 1
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