MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX834T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue plus (part # fx834t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient underwent a shunt replacement procedure on (b)(6) 2022.Reportedly, the patient was experiencing "continued symptoms, headache, etc." 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.
Additional Manufacturer Narrative
Statement: description of complaint: on (b)(6) 2022 we received the information via sap about a complained m.Blue plus.The sample or further product details (batch, serial number) are not available.Manufacturing and quality control data: no manufacturer data are available, because no product data were submitted.All m.Blue plus were finally tested, released for packaging and sterilized by miethke.No further traceability data could be checked, because missing product data.Every product has to pass a final specification test and will be shipped only after successful completion.Conclusion information: due to the missing sample, we are unable to provide a meaningful investigation.Deposits in the shunt system may possibly be responsible for the functional impairment.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 valves.However, a meaningful result requires a complete investigation of the sample.Further actions: from our point of view, no further regulatory actions are required.

• Brand Name: M.BLUE PLUS SYS W/SPRUNG RESERVOIR
• 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: 15432780
• Report Number: 3004721439-2022-00277
• Device Sequence Number: 17643919
• Product Code: JXG
• UDI-Device Identifier: 04041906504854
• UDI-Public: 4041906504854
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: FX834T
• Device Catalogue Number: FX834T
• 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: 08/17/2022
• Initial Report FDA Received Date: 09/15/2022
• 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: Required Intervention
• Patient Sex: Unknown