MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FV250T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damage, deformation of the housing, deposits or other abnormalities.The following observations were made during the visual inspection: no obvious defects.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the shuntassistant® upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the shuntassistant is permeable.Computer control test: to check the flow rate of the valve, the valve was tested on a miethke computer controlled testing apparatus and passed the standard test.The flow of the test liquid was reduced step by step from 60 ml/h to 5 ml/h (in accordance with iso 7197).Distilled water was used as the test-liquid.The resulting pressure was measured.The shuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 15 cmh2o in the vertical position, a pressure of 15 cmh2o -2 / +4 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant had a pressure of 15,81 cmh2o.This is within the specified tolerance of 15 cmh2o -2 / +4 cmh2o.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, the valve is finally opened with a special tool.After dismantling of the valve, deposits were found in shuntassistant.For more detailed visibility, the proteins/deposits in shuntassistant were coloured by using a colouring solution.[colouring solution consisting of coomassi brilliant blue r mixed with 0.6% ethanol and distilled water].Results: based on our investigation results, we can determine deposits.The deposits had no effect 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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.Further actions: from our point of view, no further regulatory actions are required.Return of product: we will return the investigated product to the sender for our own relief.
Event or Problem Description
It was reported that a shuntassistant (#fv250t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt showed an over-drainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 years, 7 months, weight: 14 kilograms (kg), height: 93.5 centimeters (cm), gender: male.Same event as #3004721439-2023-00109.

• Brand Name: SHUNTASSISTANT 15
• 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: 17401695
• Report Number: 3004721439-2023-00205
• Device Sequence Number: 2494020
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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: 05/24/2023
• Device Model Number: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 20037938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2018
• 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: 31 MO
• Patient Sex: Male
• Patient Weight: 14 KG