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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 W.SA15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W.SA15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX433T
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problem Hydrocephalus (3272)
Event Date 10/11/2023
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported that a progav 2.0 shuntsystem (#fx433t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system could not be adjusted.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.No patient data submitted and the release for investigation is still pending.
 
Manufacturer Narrative
Manufacturing site evaluation: visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the valves operates within the accepted tolerance in both positions.Adjustment test: the progav 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.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results based on our investigation results, we can determine deposits.The deposits had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.No further regulatory actions are required from our point of view.
 
Event Description
It was reported that a progav 2.0 shuntsystem (#fx433t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system could not be adjusted and showed an over-drainage.The patient underwent a revision procedure on (b)(6) 2023.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 73 years.Weight: 57 kgs.Height: 171.4 cm.Gender: male.
 
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Brand Name
PROGAV 2.0 SYS W.SA15 A.CONTROL RESERVOIR
Type of Device
HYDROCEPHALUS 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 Key18130260
MDR Text Key328033936
Report Number3004721439-2023-00332
Device Sequence Number1
Product Code JXG
UDI-Device Identifier04041906137311
UDI-Public4041906137311
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2023
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 Model NumberFX433T
Device Catalogue NumberFX433T
Device Lot Number20065354
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2023
Initial Date FDA Received11/14/2023
Supplement Dates Manufacturer Received11/23/2023
Supplement Dates FDA Received12/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient SexMale
Patient Weight57 KG
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