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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX414T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/03/2020
Event Type  Injury  
Manufacturer Narrative
Patient height: unknown. 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. 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: despite of slight scratches on the housing of the progav 2. 0 valve, no significant deformations or damage of the valves were detected during the visual inspection. Next we tested the permeability of the valves. Both valves were shown to be permeable. Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2. 0 valve. The valve was not adjustable to all settings. The brake functionality was fully operational, however due to the inability of the valve to hold a set pressure, it was not possible to measure the brake force. Finally, we have dismantled both valves. Inside both valves we have found slight build-up of substances (likely protein). Based on our investigation, we confirm that the progav 2. 0 valve was non-adjustable at the time of our investigation. 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 an issue with a progav 2. 0 shuntsystem. The reporter indicated that after 22 month and 6 days the shuntsystem was difficult or not adjustable. The shuntsystem was explanted.
 
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Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 25
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 Key10231074
MDR Text Key198310583
Report Number3004721439-2020-00124
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,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/30/2020
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 NumberFX414T
Device Catalogue NumberFX414T
Device Lot Number20036104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2017
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: 07/05/2020 Patient Sequence Number: 1
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