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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX597T
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 09/02/2019
Event Type  Injury  
Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the progav 2. 0 valve was observed through 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; however, the pressure settings could not be maintained. Braking force and brake function test the brake functionality test has shown that the brake function did not operate as expected. The results indicate that the rotor no longer performs as required. The measurement of the brake function as well as the braking force could additionally confirm that the valve characteristics were influenced by the deformation. The rotor is defect. The valve adjusts itself and does not maintain the pressure settings. Results: first, we performed a visual inspection of the progav 2. 0 shunt system. Significant scratches and damage to the outer housing of the progav 2. 0 valve were observed through the visual inspection. Next, we tested the permeability. 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 adjustable to all settings. However, the brake functionality was not 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 progav 2. 0. There were no visible deposits observed inside the valve. Based on our investigation, we confirm that the progav 2. 0 valve has adjustability issues at the time of our investigation. The cause of the deformation of the progav 2. 0 valve and the resultant defect of the rotor could not be determined through our investigation. Significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve. As described in the enclosed instructions for use, it is recommended to change the pressure level with the progav 2. 0 adjustment instrument set or the progav check mate. 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 was not adjustable. The reporter indicated that a 27 day post-operative valve is not adjustable and required explantation. Additional details of the event are not available.
 
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Brand NamePROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER
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 Key9147161
MDR Text Key160935110
Report Number3004721439-2019-00244
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 Model NumberFX597T
Device Catalogue NumberFX597T
Device Lot Number20042498
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 Manufactured06/21/2019
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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