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

Model Number	FV295T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or other abnormalities of the paedigav were detected during the visual inspection.Permeability test: a permeability test has indicated that the paedigav has a blockage.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Because the paedigav is not permeable, a computer controlled test is not possible.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 paedigav.The test indicated that the paedigav has a blockage.Then we carried out a computer controlled simulated flow test.Due to the nonpermeability of the paedigav, a computer controlled test was not possible to further investigate the claim of under-drainage.Finally, we have dismantled the paedigav.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve.We are assuming that the deposits detected have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a paedigav (#fv295t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve was believed to be operated in underdrainage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: unknown.Weight: (b)(6) kg.Gender: unknown.

• Brand Name: PAEDIGAV VALVE 9/29
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12127784
• Report Number: 3004721439-2021-00175
• Device Sequence Number: 3592201
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: FV295T
• Device Catalogue Number: FV295T
• Device Lot Number: 20031059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 MO
• Patient Weight: 7