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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 SA25 AND DISTAL CATHETER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX421T
Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative
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 both valves are 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 over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow. The progav 2. 0 valve is not operating within the accepted tolerances, but the shunt assistant is operating 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 permeable but the opening pressure was not within the tolerance. The shunt assistant was permeable and the opening pressure was within the tolerance. The opening pressure of the progav 2. 0 was significantly lower than expected, indicating a tendency towards over-drainage. 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 non- adjustability of the valve, it was not possible to measure the brake force. Finally, we have dismantled the valves. Inside both valves we have found build-up of substances (likely protein). Based on our investigation, we confirm that the progav 2. 0 valve was non-adjustable and was operating in an over-drainage state at the time of our investigation at the time of our investigation. The shunt assistant was operating within all specified tolerances. This is likely due to the deposits observed inside the valves. As described in specified 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) & co. (b)(4).
 
Event Description
It was reported that the valve was not adjustable and over drains. The reporter indicated that a 3 year 7 month post-operative valve is not adjustable and over drains requiring explantation. Additional details of the event are not available.
 
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Brand NamePROGAV 2.0 WITH SA25 AND DISTAL CATHETER
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 Key9147163
MDR Text Key166589623
Report Number3004721439-2019-00243
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 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberFX421T
Device Catalogue NumberFX421T
Device Lot Number20027939
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2015
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: 10/02/2019 Patient Sequence Number: 1
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