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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 Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/22/2019
Event Type  Injury  
Manufacturer Narrative
Height: 145 cm. Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection. Permeability test: a permeability test has shown that the valves are permeable. Adjustment test: the adjustment test has shown that the progav 2. 0 is adjustable to all settings. For the shunt assistant the adjustment test is not applicable, because it is a valve with a fixed pressure. Braking force and brake function test: the investigation of the braking force of the progav 2. 0 valve showed that the brake function is fully operational and the braking force is within the given tolerances. For the shunt assistant the test is not applicable, because it is a valve with a fixed pressure. Results: first, we performed a visual inspection of the valves. No significant deformations or damages of the valves were detected during the visual inspection. Further, we tested the permeability of the valves. The test has shown that the valves were permeable. The testing of the adjustability, the brake functionality and as well the brake force of the progav 2. 0 valve was possible and within the accepted tolerances. For the shunt assistant these tests were not applicable because it is a valve with a fixed pressure. Finally, we have dismantled the valves. Inside the progav 2. 0 valve, we have found minimal substances (likely protein). Except of slight deposits inside the progav 2. 0 valve, we cannot confirm the suspected blockage. 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). Further actions: no further actions are required in our point of view.
 
Event Description
It was reported that a valve is blocked. The reporter indicated that a 7 month 9 day post operative valve is blocked. The device was explanted. Additional event details have not been provided.
 
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Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 25
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 Key9508572
MDR Text Key185780896
Report Number3004721439-2019-00306
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161853
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 12/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX414T
Device Catalogue NumberFX414T
Device Lot Number20036057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2017
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: 12/21/2019 Patient Sequence Number: 1
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