MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 25; HYDROCEPHALUS MANAGEMENT

Model Number	FV252T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: optical inspection: first step of our investigation is the optical inspection.The visual inspection revealed that the shuntassistant has no deformations or other abnormalities.Permeability test: to proof the penetrability of the valve we carried out a permeability test.This test was carried out at a hydrostatic pressure difference of approx.25-30 cmh2o in the flow direction.The test results that the valve is penetrable, although a little more difficult.Adjustment test: an adjustment test is not applicable, because it is a valve with a fixed pressure.Braking force and brake function test: a braking force and brake function test is not applicable, because it is a valve with a fixed pressure.Computer controlled test: the test is performed with miethke computer controlled testing apparatus.The valve was tested by simulating a liquor flow between 60 ml/h down to 5 ml/h and up again to 60 ml/h in vertical position (in acc.To (b)(4)).Distilled water was used as test-liquid.Result: first we performed a visual inspection with the valve.We could not detect any deformations or other abnormalities.In the further course of investigation the valve has been tested positively for permeability even though a little difficult.As a final examination we carried out a computer controlled test.Here the shuntassistant was tested in the upright position with a pressure range of 25 cmh2o.Normally we expected a pressure of 0 cmh2o having an opening pressure of 25 cmh2o, that means that the pressure resulting from the difference of altitude is being compensated.At the first test the opening pressure at the reference flow level of 5 ml/h is measured -3,66 cmh2o.The shuntassistant operates within the accepted tolerance (0 +/- 4 cmh2o), even though at the maximum limit.Cautiously, we did a second measurement.The second measurement showed a clear improvement.The second test showed an opening pressure at the reference flow level of 5 ml/h of -2,25 cmh2o.We suspect that slight deposits inside the valve may have been flushed out by testing with the computer controlled test.In order to verify whether the valve examined here has been influenced by the known risks of hydrocephalus therapy, as for example by natural substances (protein, blood or tissue particles)1 in the cerebrospinal fluid, we have finally opened the valve.Inside the valve we could not find obvious substances of probably protein, which may have caused the suspected under-drainage in the past.Based on our investigation results we cannot confirm an underdrainage.The valve operates reliably within the accepted tolerance.There is no failure detectable with this valve at the time of delivery.
Event or Problem Description
It was reported to miethke that a shuntassistant 25 (part # fv252t) was implanted during a procedure performed in unknown date.According to the complainant, the shunt assistant was believed to be underdrainage.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: SHUNTASSISTANT 25
• Common Device Name: 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 Key: 12797759
• Report Number: 3004721439-2021-00745
• Device Sequence Number: 5644760
• Product Code: JXG
• UDI-Device Identifier: 04041906113308
• UDI-Public: 4041906113308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FV252T
• Device Catalogue Number: FV252T
• Device Lot Number: 20029342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Unknown