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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/BURRHOLE RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/BURRHOLE RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV490T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/23/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: optical inspection: first step of our investigation is the optical inspection. We could not detect any obvious deformations or other abnormalities on the progav valve. However, the measurement of the plan parallelism has shown that the valve is clearly out of the accepted tolerance, even if no obvious deformation was apparent. Permeability test: to prove the penetrability we carried out a permeability test. This test was carried out at a hydrostatic pressure difference of approx. 20-30cmh2o in the flow direction. The investigation has shown that the progav valve was permeable. Adjustment test: our adjustment tests are carried out with the standard progav checkmate and measurement tool. The valve is adjusted from 0 up to 20cmh2o and down again in the same way in steps of 5 cmh2o. It was found that every adjustment was possible. Braking force and brake function test: to measure the braking force we have investigated the valve with a braking force apparatus. Here, it is measured how much force must be exerted on the housing of the progav valve to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus. The brake function test has resulted that the brake function is full in place. However, the measurement of the braking force has shown a reduced braking force effect. The braking function is given, but less force is needed to release the rotor. Usually a failure of the braking function is in connection with a deformation of the housing membrane. Result: first we performed a visual inspection on the progav valve. We could not detect any deformations or other abnormalities. Nevertheless, the measurement of the parallelism has shown a deformation of the housing membrane. Since a deformation can impair the functionality of the brake function and the adjustability of the valve, we have made an adjustment test on the valve. It was possible to adjust the valve from 0 up to 20 cmh2o and down again in the same way in steps of 5 cmh2o. Despite the deformation the braking function is given. However, the measurement of the braking force has shown a reduced braking force effect. Therefore, less force is needed to release the rotor. We suspect that too much pressure was exerted on the housing, e. G. By progav instruments or a fall or blow, presumably the deformation was caused and thus the braking force was reduced. In order to verify whether the valve examined here has been influenced by the known risks of hydrocephalus therapy, as for example by natural substances (protein, blood or tissue particles) in the cerebrospinal fluid, we have finally opened the progav valve. After opening the progav valve, we could find slight deposits. Based on our investigation results we cannot confirm that the valve does not hold the pressure. There is no failure detectable with this valve at the time of delivery. Note: a retrospective review of potential serious injury complaints was performed. This mdr was identified and filed as part of the review activities.
 
Event Description
It was reported that there is an issue with valve. The reporter indicated that the patient's setting was set at 20h2o and when checked was at 1cmh2o. Per the reporter since the device reacted to when attempting to adjust, the doctor decided to replace only the valve since he felt the valve's setting had changed on it's own. The device was explanted. Additional event details are not available.
 
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Brand NamePROGAV SYS PED.W/BURRHOLE RESERVOIR
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 Key9953854
MDR Text Key188557187
Report Number3004721439-2020-00077
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103003
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 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV490T
Device Catalogue NumberFV490T
Device Lot Number4503697455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? Yes
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: 04/13/2020 Patient Sequence Number: 1
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