MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDI-SHUNTASSISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV288T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/24/2022
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 shuntassistant (part # fv288t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve in combination with a progav 2.0 was believed to be operating in overdrainage.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.Age: 17 years, height: 153 centimeters (cm), weight: 57 kilograms (kg), gender: female.Same event as medwatch#3004721439-2022-00435 and 3004721439-2022-00436.
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: deposits.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the paedisa upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the paedisa 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 paedisa was tested according to standard procedure in the vertical position.The results indicated that at a reference flow of 20 ml/h in the horizontal position, the paedisa had a pressure of 2.71 cmh2o.This is not within the specified tolerance of 10 cmh2o -2/+4 cmh2o.According to our results, we can detect an accelerated outflow.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 inside.For more detailed visibility, the proteins/deposits in paedisa 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 have determined that there was an accelerated outflow in the valve at the time of our investigation.Detected deposits were the cause of the accelerated outflow endogenous substances in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.We can exclude a defect at the time of release.The valve system 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.

• Brand Name: PAEDI-SHUNTASSISTANT 10
• 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: 16258210
• Report Number: 3004721439-2022-00437
• Device Sequence Number: 15145273
• Product Code: JXG
• UDI-Device Identifier: 04041906113001
• UDI-Public: 4041906113001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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 Model Number: FV288T
• Device Catalogue Number: FV288T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 17 YR
• Patient Sex: Female
• Patient Weight: 57 KG