• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FV701T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Hydrocephalus (3272)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a prosa shunt valve was removed due to a malfunction. A (b)(6) patient underwent a shunt system implantation on an unspecified date. Over a prolonged period of time, multiple valve adjustments were attempted; finally, when the desired opening pressure was achieved, overdrainage occurred. This issue led to removal of the device on (b)(6) 2018. It was noted that the patient was being treated for pseudotumor cerebri hydrocephalus. Further details have been requested but not yet received.
 
Manufacturer Narrative
Scratches to, and 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. 730mm, outside the tolerance of 0±0. 02mm. A permeability test has indicated that the valve has blockage. The valve was tested and is adjustable to all specified pressures. The break functionality test has shown that the brake function is fully operational and within tolerances. A miethke computer controlled testing apparatus was used to test the opening pressure which simulates a cerebrospinal fluid flow. Because the valve is not permeable, the computer controlled test is not possible. The valve was dismantled and inside the valve a build-up substance (likely protein) was found. Based on our investigation, we are unable to substantiate the claim of non-adjustability, the valve was found to be adjustable to all specified settings. We were unable to investigate the claim of over-drainage due to the non-permeability of the valve. However, it is possible that the deposits observed inside the vale could have caused the presumed over-drainage in the past. As describe in our literature, the problem encountered is one of the known, inevitable risks of hc therapy by shunt implants. The cause of the deformation of the prosa valve could not be determined through out investigation. It should be noted that 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 inspection when released from (b)(6) (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8126734
MDR Text Key129147646
Report Number3004721439-2018-00288
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV701T
Device Catalogue NumberFV701T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/05/2018
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Yes
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: 12/03/2018 Patient Sequence Number: 1
-
-