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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19; HYDROCEPHALUS MANAGEMENT
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CHRISTOPH MIETHKE GMBH & CO. KG PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV303T
Device Problem Free or Unrestricted Flow (2945)
Patient Problems Unspecified Infection (1930); Hydrocephalus (3272)
Event Type  Injury  
Manufacturer Narrative
(b)(4).When additional information is received, a follow up report will be submitted.
 
Event Description
It was reported that infection after implantation.Fx431-t and fv303t shunts were used in combination.Patients were implanted shunts for ventriculoperitoneal drainage.After implantation, infection occurred in the patient's brain.Then withdrew the shunt pipe.
 
Manufacturer Narrative
Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer, registration no.3004721439).Exemption number: e2017044 when additional information is received a follow up report will be submitted.
 
Event Description
It was reported that infection after implantation.Fx431-t and fv303t shunts were used in combination.Patients were implanted shunts for ventriculoperitoneal drainage.After implantation, infection occurred in the patient's brain.Then withdrew the shunt pipe.
 
Manufacturer Narrative
Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer, registration no.3004721439).Exemption number: e2017044 investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.It was observed that the paedigav was connected to a progav 2.0 shunt system with control reservoir (rm 3193).It was additional noted, that the reservoir was not properly connected to the ventricular catheter.Permeability test: a permeability test has indicated that the valve has a blockage.It was further shown that the catheters were 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 breaking force and break function test is not applicable.Results: it should be noted that the valve was received dry (i.E.Not submersed in liquid as recommended) the investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First we performed a visual inspection of the paedigav valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability of the valve.The valve was shown to have a blockage.The catheters were shown to be permeable.Finally we have dismantled the valve.Inside the valve we have found build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, likely due to the deposits observed inside the valve.As described in our 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 shunt system met all specifications of the fin inspection when release from christoph miethke gmbh & co.Kg.Associated medwatch: 3004721439-2019-00119.
 
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Brand Name
PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key8610036
MDR Text Key145085553
Report Number3004721439-2019-00120
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K011030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/12/2023
Device Model NumberFV303T
Device Catalogue NumberFV303T
Device Lot Number20037066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/21/2019
Device Age4 YR
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight60
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