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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 20 HYDRCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDRCEPHALUS MANAGEMENT Back to Search Results
Model Number FX413T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/19/2020
Event Type  Injury  
Manufacturer Narrative
Investigation result: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection. Permeability test: a permeability test has indicated that the progav 2. 0 valve has a blockage and that the shunt assistant is permeable. Adjustment test: the progav 2. 0 valve was tested and is not adjustable throughout the normal range. Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve. Computer controlled test: to investigate the claim of blockage of the valves, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow. Because the progav 2. 0 valve is not permeable, a computer controlled test was not possible. The shunt assistant operates within the accepted tolerance. 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. The progav 2. 0 valve was not permeable, therefore the claim of over/under-drainage could not be further investigated. The shunt assistant was permeable and 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 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 the valves. Inside both valves we have found significantly build-up of substances (likely protein). Based on our investigations, we confirm the presence of occlusion in the system at the time of investigation. This is likely due to the deposits observed inside the valves. As described in scientific 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). From our point of view, no further regulatory actions are required.
 
Event Description
It was reported that there was a problem with a progav 2. 0 shuntsystem. The shuntsystem is clogged. More information about the patient are not available. The patient was a premature newborn, (b)(6) week of pregnancy.
 
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Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 20
Type of DeviceHYDRCEPHALUS 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 Key10464840
MDR Text Key204700784
Report Number3004721439-2020-00171
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,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX413T
Device Catalogue NumberFX413T
Device Lot Number20038474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2018
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: 08/28/2020 Patient Sequence Number: 1
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