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	06/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ped.Prechamber (#fv035t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the prechmaber caused an occlusion.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: 2 years, 6 months.Height: 87 cm.Weight: 11 kg.Gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, deposits in the prechmaber were determined.Permeability test: a permeability test has shown that the prechmaber is not permeable.Results: based on our investigation results, we can determine an occlusion in the prechamber.The determined deposits can be named as the cause for the blockage.Organic material in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.

• 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: 19670536
• Report Number: 3004721439-2024-00187
• Device Sequence Number: 11535706
• 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
• 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): 07/03/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 30 MO
• Patient Sex: Female
• Patient Weight: 11 KG