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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 PED.W/SA25 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX442T
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative
Height: (b)(6). Investigation: visual inspection: the visual examination indicated that the catheter is detached from the shunt assistant and there are scratches on the outer housing of the progav 2. 0. Under microscopic observation, one sees clearly that the catheter was torn. No other significant deformations or damage was detected. Permeability test: a permeability test has shown that the catheter is permeable. Results: first, we performed a visual inspection of the system. Scratches on the outer casing of the progav 2. 0 were observed through the visual inspection. A tear in the distal catheter was also detected. The end of the distal catheter showed signs of having been torn apart (not cut). Next, we tested the permeability of the catheter. The test results indicate that the distal catheter is permeable. We cannot explain how the tear occurred, but there is a particular problem with still growing patients / children as described in the scientific literature. Here, growth-related shear forces or tensile forces in the connective tissue can occur, which can lead to the need to remove the catheter. It may also happen that the drainage / catheter is not long enough and causes drainage to an unintended location. Another long-term problem of shunt drainage is the calcification of the catheter walls and thus increasing the brittleness of the system. Based on our investigation, we can confirm that the catheter has broken. 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 the catheter fell out. The reporter indicated that while at an outpatient visit, it was found that the catheter in the ventral of the patient had fallen out. The catheter seemed to have fallen from the shunt assistant. Emergency surgery replacement was performed on (b)(6) 2019.
 
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Brand NamePROGAV 2.0 SYS PED.W/SA25 A.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 Key9139009
MDR Text Key162441190
Report Number3004721439-2019-00248
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberFX442T
Device Catalogue NumberFX442T
Device Lot Number20026090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2015
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: 10/01/2019 Patient Sequence Number: 1
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