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	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition).We received the valve inserted in an unknown liquid.Result: first we performed a visual inspection with the paedigav.The investigation revealed that the valve has except for scratches none no deformations or other abnormalities.In the further course of the investigation, we tested the permeability of the paedigav.The test results that the valve was not penetrable.Given the fact that during the treatment with shunts the following complications may arise: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage, we decided to dismantle the valve.Inside the valve we found slight deposits of protein, however we found very strong deposits in the nozzle the inlet side.Perhaps the deposits could have influenced the function in the past.There is no failure detectable with this paedigav at the time of delivery.No further actions required.
Event or Problem Description
According to the complainant a paedigav was blocked postoperatively.The patient was implanted on an unspecified date.About 9 years later, it appeared to have blockage.The flow was seen slightly but almost blocked.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.Height: 125 cm.

• 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
• 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: 12892813
• Report Number: 3004721439-2021-00759
• Device Sequence Number: 1491890
• Product Code: JXG
• UDI-Device Identifier: 04041906116330
• UDI-Public: 4041906116330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: 20006989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2007
• 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: 9 YR
• Patient Sex: Unknown
• Patient Weight: 23 KG