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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FV701T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implant date: (b)(6) 2018 (day unknown). When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "6m po valve is not adjustable. Explanted. " all med watch submissions related to this patient are: 3004721439-2018-00274 , 3004721439-2018-00275 (this report).
 
Manufacturer Narrative
The valve was received submerged in an unidentified liquid in a plastic container. A deformation of the outer casing of the valve was observed through the visual in specification. The prosa valve housing was measured to confirm the presence of the deformation. The housing deformation measured at -0. 0825mm, outside the tolerance of -0. 02 +-0. 02mm. The permeability test showed that the valve is permeable. However, it drains slowly indicating a possible partial blockage. The valve was tested and is adjustable to all specified pressures. The braking functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances. We performed a visual inspection of the prosa valve. A deformation of the outer casing of the valve was observed through the visual inspection. The deformation was confirmed with a measurement of the pain parallelity. Next we performed a permeability and adjustability of the valve, as well as the brake functionality and brake force. The valve was permeable but drained slowly indicating a possible partial blockage the valve met all other specifications. Finally, we have dismantled the valve. Inside the prosa we have found a buildup of substance (likely protein). Based on our investigation, we are unable to substantiate the claim of non-adjustability. The valve operates within the specified tolerances. Therefore, it is possible that the deposits observed inside the valve could have caused the malfunction in the past. The cause of the deformation of the prosa valve could not be determined through our investigation. Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve. We can exclude a defect at the time of release. The valve met all specifications of the final inspections.
 
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Brand NamePROSA VALVE
Type of DeviceHYDROCEPHALUS VALVES
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8063788
MDR Text Key126933168
Report Number3004721439-2018-00275
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care 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
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV701T
Device Catalogue NumberFV701T
Device Lot Number20036639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/28/2018
Device Age9 MO
Event Location No Information
Date Manufacturer Received11/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2018
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: 11/13/2018 Patient Sequence Number: 1
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