MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PRECHAMBER PED.; HYDROCEPHALUS MANAGEMENT

Model Number	FV035T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: deposits in the prechamber were determined through the visual inspection.2.5.Permeability test a permeability test has shown that the pediatric prechamber is permeable.2.6.Internal inspection to make the deposits in the pediatric prechamber more visible, they were colored using a staining solution.3.Results: based on our investigation results, we can detect visible deposits in the pediatric prechamber.The deposits did not affect the technical properties at the time of the investigation.We can exclude a defect at the time of release.The prechamber met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
Event or Problem Description
It was reported that a ped.Prechamber (#fv035t) and a m.Blue (#fxt802) were implanted during a procedure performed on (b)(6) 2023.According to the complainant, the prechamber caused an 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: 10 years height: 145 cm weight: 35 kg gender: female *same event as medwatch#3004721439-2024-00067.

• Brand Name: PRECHAMBER PED.
• 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: 18911942
• Report Number: 3004721439-2024-00068
• Device Sequence Number: 7026749
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: 02/23/2026
• Device Model Number: FV035T
• Device Catalogue Number: FV035T
• Device Lot Number: 20051922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 35 KG