MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG VENTRICULAR CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV078P
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the missing product information (e.G.Serial number/ delivery notes batch) we were not able to trace the affected batch.We can assure you that all our products are manufactured by qualified staff.An examination of the ventricular catheter was not possible, because we did not receive the product for further analysis.However, it is possible that deposits affected the function of the product.Deposits due to natural substances in the csf, such as protein, blood or tissue particles, as well as blockages are among the known and unavoidable risks and side effects of hydrocephalus therapy.A final clarification of what has led to the blockage would only be possible by examining the product.No further regulatory actions are required from our point of view.
Event or Problem Description
Via a patient's social media posting, information was shared that an emergency surgery was performed due to ventricular catheter occlusion.The complaint device was not available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Implantation: (b)(6) 2021, explantation: (b)(6) 2023.

• Brand Name: VENTRICULAR CATHETER
• 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: 17086978
• Report Number: 3004721439-2023-00160
• Device Sequence Number: 6173108
• Product Code: JXG
• UDI-Device Identifier: 04041906120504
• UDI-Public: 4041906120504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: FV078P
• Device Catalogue Number: FV078P
• 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: 05/08/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Female