MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV VALVE 9/29; HYDROCEPHALUS VALVES

Model Number	FV295T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: visual inspection: no significant deformation or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable, albeit with difficulty.Computer controlled test: to investigate the claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The first measurement showed that the valve in the horizontal body position is with a value of 16.29 cmh2o outside the tolerance (9 cmh2o± 2 cmh2o).The valve shows, contrary to the suspected overdrainage an underdrainage.In the second test a minimal improvement in the values was observed.With a measured value of 15.54 cmh2o, the valve was still out of tolerance.The test run in vertical position has shown that the valve in the reference flow range of 5 ml/h with a measured value of 0.66 cmh2o works within the tolerance (0 cmh2o ± 4 cmh2o).Results: first, we performed a visual inspection of the paedigav.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to be permeable, albeit with difficulty.Then we carried out a computer controlled simulated flow test.The measured opening pressure was within the accepted tolerance in the vertical position but not in the horizontal position.Contrary to the suspected overdrainage the valve tends to underdrain.Finally, we have dismantled the valve.Inside and outside the valve we have found salt-like substances.The deposits detected could have settled in the valve and caused functional impairments (non-permeability, under- and overdrainage).The cause of the valve blockage cannot be clearly determined retrospectively.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was an issue with paedigav valve 9/29 (#fv295t).According to the complainant, the valve was believed to be overdrainage.The complainant device was returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PAEDIGAV VALVE 9/29
• Common Device Name: HYDROCEPHALUS VALVES
• 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: 12926937
• Report Number: 3004721439-2021-00797
• Device Sequence Number: 4957895
• Product Code: JXG
• UDI-Device Identifier: 04041906114565
• UDI-Public: 4041906114565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• 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): 12/03/2021

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: 05/30/2022
• Device Model Number: FV295T
• Device Catalogue Number: FV295T
• Device Lot Number: 20034011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2017
• 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