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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV414T
Device Problem Decrease in Pressure (1490)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/08/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing and quality control data. The progav® shunt system was manufactured by a qualified employee in (b)(6) 2019. Deviations during assembly did not occur. The system was sterilized by miethke and released for shipment after final inspection. For the purposes of this investigation, the progav® shunt system is comprised of a progav®. The shunt system was inspected as article fv414t. All parameters have been inspected and approved during the manufacturing process. All parameters have been assessed as meeting specifications. Investigation reference number (b)(4). Description of incoming product condition: the valve was received in the return kit, submersed in an unidentified liquid. When delivered for examination, the progav® was set to a pressure level of 6 cmh2o. Visual inspection: in the first step of our investigations an optical control is carried out. It is checked whether any defects, deformations or other noticeable irregularities can be identified. Permeability test: in order to check whether the progav® is permeable, the valve was tested for permeability. We carried out this test at a set opening pressure of 6 cmh20 as well as 11 cmh20 in horizontal flow direction. Computer controlled test: to investigate the suspected overdrainage, the progav® was tested on the miethke test stand. It passed the standard test for the horizontal position at a set opening pressure of 6 cmh20 as well as 11 cmh20. The liquor flow was gradually reduced from 60 ml/h to 5 ml/h (in accordance with iso 7197). The resulting pressure was measured. Adjustment test: the adjustment test is used to ensure that the progav® can be adjusted to all pressure levels. The tests are carried out with the standard progav® check-mate and measurement tool. The progav® valve was adjusted from 0 to 20 cmh2o in increments of 5 cmh2o. Braking force and brake function test: to measure the braking force, we tested the progav® with a braking force apparatus. Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus. Results: during the visual inspection, slight scratches were found, but no visible deformation of the case surface or other apparent damage. The liquid in the transport container was clearly bloody. The measurement of the plane parallelism could additionally verify that there is no deformation of the housing surface. The permeability test proved that the progav® is permeable. In addition, we could prove that the valve maintains the respective pressure difference. Especially at the set pressure level of 6 cmh20 we cannot confirm a complete flow without resistance. In addition, it could be observed that clearly bloody liquid escaped from the valve. Further, we have tested the progav® on the miethke test stand. It passed the standard test for the lying position. The test bench measurement at a set opening pressure of 6 cmh20 showed that the progav® worked within the permissible tolerance (permissible tolerance 6 cmh2o ± 3 cmh2o). To verify the measured value, we performed a second measurement. The second measurement showed that the progav® worked outside the permissible tolerance (permissible tolerance 6 cmh2o ± 3 cmh2o). During our measurement an overdrainage could be detected. Furthermore, the progav® passed the standard test in the horizontal body position at a set opening pressure of 11 cmh2o. The measurement showed that the progav® worked outside the permissible tolerance (permissible tolerance 11 cmh2o ± 3 cmh2o). During our measurement an overdrainage could be detected. In addition, we could also observe that blood continued to leak from the valve. It was possible to adjust the progav® in all pressure ranges. The braking force of the progav® was within the specified tolerance and the brake function operated as expected. Finally, we have dismantled the valve. After opening the valve, minimal deposits were found inside the progav®. We have to assume that most of the deposits (especially blood) were flushed out in the previous tests. Based on our examination results, we can confirm the suspicion of "overdrainage" at the time of our examination. We suspect that the massive deposits found inside the valve have led to the functional impairment (csdh). However, even small amounts of non-visible deposits could endanger the integrity of the valve. Deposits caused by natural substances found in the csf, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy. We can exclude a defect at the time of release. The progav® shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
It was reported that there was a problem with a progav. According to the doctor's assessment and based on the information provided in the questionnaire, the reporter suspected an overdrainage / malfunction on the valve. The patient has an increased protein content > 2,000 mg/l and narrowed ventricles. It is known that further revisions have already taken place in advance. Diagnosis according to questionnaire: csdh (chronic subdural hematoma) on both sides. Patient information: age: (b)(6). Weight: (b)(6) kg. Hight: 51 cm. Gender: male.
 
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Brand NamePROGAV WITH SHUNTASSISTANT 25
Type of DeviceHYDROCEPHALUS 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 Key10430485
MDR Text Key203645381
Report Number3004721439-2020-00173
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103003
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV414T
Device Catalogue NumberFV414T
Device Lot Number20044687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2019
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: 08/20/2020 Patient Sequence Number: 1
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