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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV 2.0 SYS W/PED.CONTROL RESERV.5/35 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG GAV 2.0 SYS W/PED.CONTROL RESERV.5/35 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX155T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/22/2019
Event Type  Injury  
Manufacturer Narrative
Height: 160 cm. Investigation: visual inspection the optical inspection showed particles/residues on, in the reservoir, and on the valve, but no other obvious damage. Permeability test: a permeability test has shown that the valve is permeable. Adjustment test: this is a fixed pressure valve. An adjustment test is not applicable. Braking force and brake function test: this is a fixed pressure valve. A braking force and brake function test is not applicable. Results: first, we performed a visual inspection of the gav 2. 0. The optical inspection showed particles/residues on, in the reservoir, and on the valve, but no other obvious damage. Next, we tested the permeability of the valve. The valve was shown to be permeable. Finally, we have dismantled the valve. Inside the valve, we have found a build-up of substances (likely protein). Based on our investigation, we are unable to substantiate the claim of occlusion. At the time of our investigation, the valve was shown to be permeable. However, it is possible that the deposits observed inside the valve could have caused the 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. We can exclude a defect at the time of release. The valve met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
It was reported that a valve is blocked. The reporter indicated that a 4 year 2 month post operative valve is blocked. The device was explanted. Additional event details have not been provided.
 
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Brand NameGAV 2.0 SYS W/PED.CONTROL RESERV.5/35
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 Key9448429
MDR Text Key185503828
Report Number3004721439-2019-00286
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
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 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX155T
Device Catalogue NumberFX155T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
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: 12/10/2019 Patient Sequence Number: 1
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