MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 10 A.BURRH.RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV446T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information /investigation result will be provided in a supplemental report when the product returned.
Event or Problem Description
It was reported that there was a problem with a progav shuntsystem.It was implanted in patient.The pressure could not be adjusted, fixed at 8 cmh2o.It was suspected that the valves operated in under-drainage.The complaint sample consists of adjustable differential pressure unit (series# (b)(4)) and gravitational unit (series# (b)(4)).The patient was without harm, but a surgical intervention was conducted.A new progav was replaced and implanted.Patient informations: aga.(b)(6) years.Height: 80 cm.Weight: (b)(6).Gender: male.Implantation: (b)(6) 2019.Removal: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation was done on 11/23/2020.Visual inspection: the following observations were made during the visual inspection: no visible defects or other abnormalities are detected.Measurement of surface of the housing: the measurement of the plane parallelism confirmed the observations of the optical inspection.The measured value of - 0.016 mm lies within the given tolerance (0 ± 0.02mm).Permeability test: the test showed that the progav shunt system is permeable.Computer control test: the computer controlled test has shown the opening pressure of the progav, at a reference flow rate of 20 ml/hr in a horizontal position, to be 0.66 cmh2o.This is not within the specified tolerance of 9 cmh2o ± 3 cmh2o.An applied pressure of 9 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 9 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can determine the presence of an over- drainage.Additionally, the shunt assistant was tested according to standard procedure in the vertical position.At a fixed opening pressure of 10 cmh2o in the vertical position, a pressure of 10 cmh2o +2/-4 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the vertical position, the shunt assistant had a pressure of 25.21 cmh2o.This is not within the specified tolerance of 10 cmh2o + 2 /-4 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm a presence of an under- drainage.Adjustability test: the progav was found to be not adjustable to specifications.The shunt assistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force test indicates that the brake function of the progav is present.Due to the non-adjustability of the valve, an investigation of the braking force was not possible.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, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in both valves.Results: based on our investigation, we are able to substantiate the claim of "non- adjustability" and "under- drainage ".We are assuming that the deposits detected within the valves 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.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
The product was received for investigation on 11/18/2020 and investigated on 11/23/2020.

• Brand Name: PROGAV SYS PED.W/SA 10 A.BURRH.RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10868326
• Report Number: 3004721439-2020-00240
• Device Sequence Number: 2521623
• Product Code: JXG
• UDI-Device Identifier: 04041906132668
• UDI-Public: 4041906132668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 07/09/2023
• Device Model Number: FV446T
• Device Catalogue Number: FV446T
• Device Lot Number: 20038588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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
• Patient Age: 2 YR
• Patient Weight: 11