MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/BURRHOLE RESV.4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV298T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: manufacturing and quality control data: the paedigav was manufactured by a qualified employee in may 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The paedigav has a normal pressure range of 4/24 cmh2o.The valve was inspected as article fv298t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation statement: on the basis of juristic requirements we have to get the personal request by the surgeon as a step of safeguard.Unfortunately we did not receive a consent.An official release is missing for the investigation of the product.For this reason, we returned the product for our discharge without examination.Results: 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 fv298t - paedigav system w/burrhole resv.4/24.According to the complainant, post operative the paedigav system has technical problems.Additional information was not available.

• Brand Name: PAEDIGAV SYSTEM W/BURRHOLE RESV.4/24
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12466840
• Report Number: 3004721439-2021-00631
• Device Sequence Number: 3793928
• Product Code: JXG
• UDI-Device Identifier: 04041906116330
• UDI-Public: 4041906116330
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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 Model Number: FV298T
• Device Catalogue Number: FV298T
• Device Lot Number: 20030282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2016
• Initial Report FDA Received Date: 09/14/2021
• 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