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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SHUNTSYSTEM HYDROCHEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SHUNTSYSTEM HYDROCHEPHALUS MANAGEMENT Back to Search Results
Model Number FX602T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
Height: 160 cm. Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection. Permeability test: a permeability test has shown that both valves are permeable. Adjustment test: the progav 2. 0 valve was tested and is adjustable to all specified pressures. Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances. Results: first we performed a visual inspection of the progav 2. 0 shunt system. No significant deformations or damage of the valves were detected during the visual inspection. Next we tested the permeability and opening pressure of the valves. Both valves were shown to be permeable and their opening pressures were operating within specifications. 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 the valves. Inside the progav 2. 0 valve we have found slight build-up of substances (likely protein). There were no visible deposits observed inside the shuntassistant 2. 0. Based on our investigation, we are unable to substantiate the claim of occlusion. At the time of our investigation, the valves were shown to be permeable. However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past. As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants. 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 the valve has a blockage. Due the malfunction, the valve was revised on (b)(6) 2020. Additional information was not provided.
 
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Brand NamePROGAV 2.0 SHUNTSYSTEM
Type of DeviceHYDROCHEPHALUS 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
jörg knebel
ulaneweg 2
potsdam 14469
GM   14469
MDR Report Key10128856
MDR Text Key194465019
Report Number3004721439-2020-00100
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 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX602T
Device Catalogue NumberFX602T
Device Lot Number20043460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2020 Patient Sequence Number: 1
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