MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX215T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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 gav 2.0 (part # fx215t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to be operated in underdrainage and the surgeon suspected a failure of the valve.The patient underwent a revision procedure on (b)(6) 2020.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.No patient data are available.
Event or Problem Description
Additional information: gender: male.
Additional Manufacturer Narrative
Additional information: a3 , b5 investigation: visual inspection: the following observations were made during the visual inspection: - a bacteseal catheter was used (not from christoph miethke gmbh & co kg) - small visible holes in the catheter permeability test: the test showed that the gav 2.0 is non-permeable.Computer control test: the computer controlled test was not applicable, because the detected blockage in capitel "permeability test".Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, some deposits were found in gav 2.0.Results: based on our investigation results, we can identify a blockage in the valve.We are assuming that the deposits detected within the valve have caused 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 valve.We can exclude a defect at the time of release.The valve 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: GAV 2.0 VALVE 10/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11793879
• Report Number: 3004721439-2021-00114
• Device Sequence Number: 11773101
• Product Code: JXG
• UDI-Device Identifier: 04041906500054
• UDI-Public: 4041906500054
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 10/07/2024
• Device Model Number: FX215T
• Device Catalogue Number: FX215T
• Device Lot Number: 20044097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention