MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX603T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a control reservoir (part # fx603t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system including the reservoir, was believed to be clogged.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 44 years, height: 180 centimeters (cm), weight: 85 kilograms (kg), gender: unknown.
Additional Manufacturer Narrative
Investigation: visual inspection: damaged membrane.-nterior turbid.Permeability test: the examination showed that the control reservoir is not permeable.In order to investigate at where the reservoir is clogged, we disassembled the inlet spout.We could determine that the spout is also non-permeable.An additional test showed that the outlet spout of the reservoir is permeable.Internal inspection : after disassembling of the inlet spout, deposits were found inside.Results : based on our examination results, we can detect a blockage in the control reservoir at the time of our examination.The detected deposits can be named as the cause of the blockage.Deposits caused by substances naturally present in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise the integrity of the valve.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: CONTROL 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: 15936508
• Report Number: 3004721439-2022-00364
• Device Sequence Number: 17752938
• Product Code: JXG
• UDI-Device Identifier: 04041906503239
• UDI-Public: 4041906503239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/07/2022

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: FX603T
• Device Catalogue Number: FX603T
• Device Lot Number: 20060715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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: 44 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG