MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DUALSWITCH-VALVE 10/40 L P DERIVATION; HYDROCEPHALUS MANAGEMENT

Model Number	FV128T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to qab 2154.Investigation: ( description incoming product condition).The valve was returned in a plastic container with unknown liquid.Summary: in the visual inspection of the valve, we could has scratches determine but not deformations or other abnormalities.In the further course of the investigation, we tested the permeability of the dsv valve.The test results that the valve was penetrable.In order to check the assumed uver-drainage, we carried out a computer controlled test.Horizontal position: at the first test an opening pressure at the reference flow level of 5 ml/h is measured 20,22 cmh2o.Based on the first result we can confirm an under-drainage.We execute a second test.The second test showed not clear improvement of the valve, the measured values are still outside the accepted tolerance.The second test showed a opening pressure at the reference flow level of 5 ml/h of - 20,17 cmh2o as well.We suspect the deposits inside the valve could have impaired the function.Vertical position: at second the dsv was tested in the upright position.Based on the opening pressure of 40 cmh2o in upright position an opening pressure of 0 cmh2o is expected.(the pressure resulting from the difference of altitude is being compensated by the valve.) the accepted tolerance range for the opening pressure of 30 cmh2o in upright position is 0 ± 4 cmh2o.The measured opening pressure of 6,07 cmh2o was over the accepted tolerance range.Therefore, we have the performed a second test.The second test showed even slight a deterioration at a value with 7,33 cmh2o ( 0 ± 4cmh2o).We can confirm the suspicion of one under-drainage according to our measurements.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage we decided to dismantle the valves.Inside the valve we found visible deposits that may have caused the assumed under-drainage.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a valve was not draining postoperatively.The device was originally implanted on (b)(6) 2016.It was explanted due to kinking of catheter and non-drainage on (b)(6) 2017; both the catheter and the dual switch valve were replaced.Further details were not provided.

• Brand Name: DUALSWITCH-VALVE 10/40 L P DERIVATION
• 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: 12919402
• Report Number: 3004721439-2021-00772
• Device Sequence Number: 4983264
• Product Code: JXG
• UDI-Device Identifier: 04041906103804
• UDI-Public: 4041906103804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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 Model Number: FV128T
• Device Catalogue Number: FV128T
• Device Lot Number: 20027908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown