MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG XABO CATHETER-SET; HYDROCEPHALUS MANAGEMENT

Model Number	FY040A
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheter set was implanted as part of a pmcf study with a miethke subsystem (no data available).Due to an infection, the devices were replaced.No patient data available.No patient harm reported.Reason for explantation: infection, gram positive cocci (staphylococcus capitis, staphylococcus caprae, staphylococcus epidermidis).
Additional Manufacturer Narrative
We were unable to examine the xabo catheter set as we did not receive any product for further analysis.Infection is a known side effect.Feedback on the product will be monitored and evaluated in accordance with art.89 and as part of the pmcf study.This letter concludes the complaint process.

• Brand Name: XABO CATHETER-SET
• 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: 21344939
• Report Number: 3004721439-2025-00036
• Device Sequence Number: 15693073
• Product Code: JXG
• UDI-Device Identifier: 04041906506742
• UDI-Public: 4041906506742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FY040A
• Device Catalogue Number: FY040A
• Device Lot Number: 20076440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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 Sex: Unknown