MAUDE Adverse Event Report: 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	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the paedigav was manufactured by a qualified employee in april 2013.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The paedigav has a fixed pressure of 9 cmh20 in the horizontal and 29 cmh20 in the vertical position.The valve was inspected as article fv295t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable.Result first, we performed a visual inspection of the paedigav.No significant deformations or damage to the valve were detected during the visual inspection.Next, the permeability of the valve was tested.The valve was shown to be permeable.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of occlusion was not able to substantiated as the valve was found to be permeable.However, it is possible that the deposits observed inside the valve may have led to the malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported miethke that a paedigav valve 9/29 (part # fv295t) was implanted during a procedure performed on (b)(6) 2017.According to the complainant, the valve was believed to be blocked.The patient underwent a revision procedure on (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PAEDIGAV VALVE 9/29
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12746642
• Report Number: 3004721439-2021-00720
• Device Sequence Number: 14572988
• 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: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 12/31/2017
• Device Model Number: FV295T
• Device Catalogue Number: FV295T
• Device Lot Number: 20019700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2013
• 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: 30 YR