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	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a control reservoir (partt # fv049t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the reservoir was believed to be blocked.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.Same event as medwatch# 3004721439-2022-00320.
Event or Problem Description
Same event as medwatch# 3004721439-2022-00320.
Additional Manufacturer Narrative
Additional information - d4 (serial #).Investigation: visual inspection: the following observations were made during the visual inspection: -bloody deposits in the control reservoir.Permeability tes: the test showed that the control reservoir is permeable.Results: based on our investigation results, we can determine deposits.The deposits had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.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.

• 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: 15654987
• Report Number: 3004721439-2022-00319
• Device Sequence Number: 2530602
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: 20057568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: 10 YR
• Patient Sex: Unknown