MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG BURR HOLE RESERVOIR PED; HYDROCEPHALUS MANAGEMENT

Model Number	FV039T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a paedi bohrlochreservoir (#fv039t) was implanted during a procedure performed on (b)(4) 2021.According to the complainant, the shunt showed a under-drainage and blockage.The patient underwent a revision procedure performed on (b)(4) 2023.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 years, 6 months, weight: 10.4 kilograms, height: 82.7 centimeters, gender: male, same event as # 3004721439-2023-00311, and # 3004721439-2023-00313.
Additional Manufacturer Narrative
Manufacturing site evaluation: conclusion information: an investigation was not possible because no product was sent for investigation.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the pediatric burrhole reservoir, since this documentation indicates that the valve is in perfect condition.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.Further actions: additional actions will be implemented in form of a authorities notification.

• Brand Name: BURR HOLE RESERVOIR 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: 18049306
• Report Number: 3004721439-2023-00312
• Device Sequence Number: 18161926
• Product Code: JXG
• UDI-Device Identifier: 04041906116408
• UDI-Public: 4041906116408
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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 Expiration Date: 02/16/2026
• Device Model Number: FV039T
• Device Catalogue Number: FV039T
• Device Lot Number: 20051903
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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: 30 MO
• Patient Sex: Male
• Patient Weight: 10 KG