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

Model Number	FV035T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no abnormalities of the prechamber was determined.Permeability test: a permeability test has shown that all components are permeable.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.
Event or Problem Description
It was reported that a pediatric prechamber (#fv035t) was implanted during a procedure.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: 5 months, height: 56 cm, weight: 4.95 kg, gender: male.Same event as medwatch#: 3004721439-2024-00106 + medwatch#: 3004721439-2024-00107.

• Brand Name: PEDIATRIC PRECHAMBER
• 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: 19225917
• Report Number: 3004721439-2024-00108
• Device Sequence Number: 15527445
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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 Model Number: FV035T
• Device Catalogue Number: FV035T
• Device Lot Number: 20072338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG