MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DUALSWITCH-VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV100T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a dualswitch-valve operated in over-drainage postoperatively.The valve was implanted on (b)(6) 2017.It was removed on (b)(6) 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.Height: 168 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to qab 2154.Investigation ( description incoming product condition) the product was received in the returnkit container with an unknown liquid.Result in the visual inspection of the valve we have detected scratches on the surface of the device but not deformation or other abnormalities.In the further course of the investigation, we tested the permeability of the dsv valve.The test results showed that the valve was penetrable.In order to check the assumed over-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 19.41 cmh2o.Based on the first result we have detected an under-drainage.We executed a second test.The second test showed no clear improvement of the valve, the measured values are still outside the accepted tolerance.The second test showed an opening pressure at the reference flow level of 5 ml/h of 18.79 cmh2o as well.We suspect 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 4.76 cmh2o was slightly outside of the accepted tolerance range.According to our measurements we have been able to assess an over-drainage instead of an under-drainage.But it is considered that we are just able to assess the current situation with the valve.It is indeed possible that temporarily an over-drainage happened.Given the fact that during the treatment with shunts the following complications may arise (as described in the scientific literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid (csf), over/under drainage, we decided to dismantle the valves.Inside the valve we have found visible deposits that may have caused the assumed under-drainage.In our point of view there is no failure detectable with the valve at the time of delivery.In addition, the under-drainage is a known and unchangeable risk of hc-therapy with shunts.No further actions required.

• Brand Name: DUALSWITCH-VALVE 10/30
• 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: 13005495
• Report Number: 3004721439-2021-00817
• Device Sequence Number: 17335649
• Product Code: JXG
• UDI-Device Identifier: 04041906101008
• UDI-Public: 4041906101008
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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: 11/15/2021
• Device Model Number: FV100T
• Device Catalogue Number: FV100T
• Device Lot Number: 20032270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2016
• 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: 19 YR
• Patient Sex: Unknown
• Patient Weight: 53 KG