MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE W/MININAV 10 DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV709T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deformation of the housing.Deposits on the ligature.Measurement of surface of the housing: deformation detected: yes - measured value: - 0.061 mm [tolerance (0 ± 0.02mm)] - value outside tolerance too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the test showed that the prosa shunt system is permeable.Computer control test: the computer controlled test showed the opening pressure of the prosa, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 7.44 cmh2o.This is not within the specified tolerance of 19 cmh2o +7/-8 cmh2o.An applied pressure of 19 cmh2o, with the device in the vertical position is expected to have a resultant pressure of 19 cmh2o +7/-8 cmh2o.According to our result, we determined a presence of an accelerated outflow.Additionally, the mininav was tested according to standard procedure in the horizontal position of the valve.At a fixed opening pressure of 10 cmh2o in the horizontal position, a pressure of 10 cmh2o +3/-1 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the horizontal position, the mininav had a pressure of 12.01 cmh2o.This is within the specified tolerance of 10 cmh2o +3/-1 cmh2o.Adjustability test: the prosa was found to be adjustable to all pressure settings.The mininav is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force of the prosa was within the specified tolerance and the brake function operated as expected.Internal inspection of product: in order to verify whether the investigated shunt system 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 valves are finally opened with a special tool.After dismantling of the valves, deposits were found in prosa.In the mininav were no visible deposits.Results: we are obliged to inform you that the condition of the product could be affected due to the interval between the explantation date and the shipping of the product, because fungus and mold can develop.Based on our investigation results, we have determined that there was an accelerated outflow in the prosa and a deformation of the outer housing.Additionally, we can determine deposits.The deformation had no effect to the adjustability at the time of the investigation.Detected deposits could be the cause of the accelerated outflow.Existing deposits 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 shunt system 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.
Event or Problem Description
It was reported that a prosa shuntsystem with mininav (part # fv709t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system was believed to be blocked and not adjustable.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: 37 years.Height: 170 centimeters (cm).Weight: 88 kilograms (kg).Gender: unknown.

• Brand Name: PROSA VALVE W/MININAV 10 DIST.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: 15112448
• Report Number: 3004721439-2022-00213
• Device Sequence Number: 5874655
• Product Code: JXG
• UDI-Device Identifier: 04041906133580
• UDI-Public: 4041906133580
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 07/27/2022

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 Expiration Date: 09/10/2022
• Device Model Number: FV709T
• Device Catalogue Number: FV709T
• Device Lot Number: 20035109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2017
• 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: 37 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG