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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.PED.PRECHAMBER; HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.PED.PRECHAMBER; HYDROCEPHALUS VALVES Back to Search Results
Model Number FX998T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date of event: unknown.Date of explant: unknown.When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "that there was no possibility of subcutaneous parameter changes.Device explanted.".
 
Manufacturer Narrative
Manufacturing and quality control data: all parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation: visual inspection: a deformation of the outer housing of the valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.130mm, outside the tolerance of 0 +/- 0.02mm.Permeability test: a permeability test has indicated that the valve has a blockage.Adjustment test: the valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: we have dismantled the valve.Inside the valve we have found significant build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.The valve is adjustable to all specified settings.However, through the investigation we have determined that the prosa valve is occluded, likely due to the deposits obsereved inside the valve.As described in our literature, the problem encountered is one of the known inevitable risks of hc-therapy by shunt implants.
 
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Brand Name
PROSA SYS W/PROGAV 2.0 A.PED.PRECHAMBER
Type of Device
HYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key8101867
MDR Text Key128278905
Report Number3004721439-2018-00277
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Model NumberFX998T
Device Catalogue NumberFX998T
Device Lot Number20026762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Distributor Facility Aware Date11/05/2018
Device Age3 YR
Initial Date Manufacturer Received 09/28/2018
Initial Date FDA Received11/26/2018
Supplement Dates Manufacturer Received12/04/2018
Supplement Dates FDA Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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