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

Model Number	FV049T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a control reservoir (part # fv049t) was implanted during an abdominal shunt surgical procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be blocked.Reportedly, a post operative re-examination found that the patient's cerebrospinal fluid was not able to be shunted out.Therefore, the patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Same event as medwatch # 3004721439-2022-00258.
Additional Manufacturer Narrative
Manufacturing and quality control data the m.Blue® was manufactured by a qualified employee on january 2022.Deviations during assembly did not occur.The product was finally tested as article fv049t and released for packaging and sterilization and was sterilized by miethke.All tested parameters were assessed according to specifications.Visual inspection the following observations were made during the visual inspection: deposits on the reservoir.Permeability test.The test showed that the progav® 2.0 shunt system with the control reservoir are permeable.Results.Based on our investigation results, we cannot detect a blockage in control reservoir at time of investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.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.

• Brand Name: CONTROL RESERVOIR SET WITH 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: 15320475
• Report Number: 3004721439-2022-00259
• Device Sequence Number: 20210064
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: FV049T
• Device Catalogue Number: FV049T
• Device Lot Number: 20057344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: 67 YR
• Patient Sex: Unknown