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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX991T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/03/2019
Event Type  Injury  
Manufacturer Narrative
Visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection. The prosa valve housing was subsequently measured and confirmed/indicated the presence of a deformation. The housing deformation measured at -0. 0595 mm, outside the tolerance of 0 ± 0. 02 mm. Permeability test: a permeability test has shown that the prosa shunt system is permeable. Adjustment test: the prosa valve and the progav 2. 0 valve were tested and are adjustable to all specified pressures. Braking force and brake function test: the brake functionality test by both valves 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 prosa shunt system. A deformation of the outer housing of the prosa valve was observed through the visual inspection. This deformation was confirmed through a measurement of the plan parallelity. Next, we tested the permeability, adjustability, as well as the brake functionality and brake force. The prosa and the progav 2. 0 valve operates as expected and met all specifications. Finally, we have dismantled the valves. There were no visible deposits observed inside the prosa valve, inside the progav 2. 0 are minimal visible deposits. Based on our investigation, we are unable to substantiate the claim of occlusion. At the time of our investigation, the prosa shunt system was shown to be permeable. Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past. As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants. The cause of the deformation of the prosa valve could not be determined through our investigation. Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve. 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 gmbh & co. Kg.
 
Event Description
It was reported that a valve is blocked. The reporter indicated that a 2 year 5 month post operative is blocked and required explantation. Additional event details have not been provided. A request for additional information has been made, however, not yet received.
 
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Brand NamePROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
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 Key9409410
MDR Text Key169243835
Report Number3004721439-2019-00282
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K141687
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 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX991T
Device Catalogue NumberFX991T
Device Lot Number20034719
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2017
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: 12/04/2019 Patient Sequence Number: 1
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