MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROLRESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV049T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: reservoir twisted to the rest of the shunt system, deposits on the reservoir, small hole in the catheter between reservoir and progav 2.0.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the complete system upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the complete progav 2.0 shunt system is permeable.The ventricular catheter was separated from the system for the test and was also permeable.Results: for the sake of thoroughness and transparency, we would like to point out that a permeability test was already carried out after the revision at the hospital.Based on our investigation results, we can determine no functional deviation in the control reservoir and ventricular catheter.The cause of the above functional impairment could be due to deposits in the shunt system (report of rm 4742_1 - cc400607180).Proteins 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 control reservoir met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a control reservoir set (part#: fv049t) in combination with a progav 2.0 (part#: fx420t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the catheter of the system caused a blockage.The patient underwent a revision procedure.The complaint device will be return to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Same event as medwatch#: 3004721439-2023-00198.

• Brand Name: CONTROLRESERVOIR SET W/DISTAL CATHETER
• 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: 17375265
• Report Number: 3004721439-2023-00197
• Device Sequence Number: 14381484
• Product Code: JXG
• UDI-Device Identifier: 04041906131487
• UDI-Public: 4041906131487
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/21/2023

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: 08/23/2026
• Device Model Number: FV049T
• Device Catalogue Number: FV049T
• Device Lot Number: 20054737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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 Sex: Unknown