MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 15 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV494T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Description of product upon intake the shunt system was returned to us in a plastic container submersed in an unidentified liquid.The following products were submitted for return: progav shunt system with prechamber.Opening pressure upon intake: at the time of intake, the progav showed a pressure setting of 19 cmh2o.Investigation: visual inspection: the following observations were made during the visual inspection: deposits in the prechamber are visible.Measurement of surface of the housing: the measurement of the plane parallelism showed a slightly deformation of the outer housing.The measured value of -0,0225 mm lies slightly outside the given tolerance (0 ± 0.02mm).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 progav shunt system is permeable.During the test, small deposits were flushed out.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 20.97 cmh2o.This is within the specified tolerance of 19 cmh2o ± 3 cmh2o.Adjustability test: the progav was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav was within the specified tolerance and the brake function operated as expected.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, slightly deposits were found in the progav.Results: based on our investigation, we are not able to substantiate the claim of "over-drainage" or "self- adjustment".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.However, we suspected that the slightly deposits found within the valve may have temporarily 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.Even small amounts of non-visible deposits might compromise the integrity of the valve.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 (b)(4).From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that there was a problem with a progav valve.The surgeon suspected an over-drainage resulting from uncontrolled shunt's self-adjustment.Patient information: age: (b)(6) years.Weight: unknown.Height: unknown.Gender: unknown.Implantation: (b)(6) 2020.Removal: (b)(6) 2020.The valve was implanted parallel to the body axis.Following products were implanted (not a complete miethke shunt system): fv467t + miethke peritoneal catheter + miethke ventricular catheter with deflector.

• Brand Name: PROGAV SYS W/SA 15 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10748198
• Report Number: 3004721439-2020-00217
• Device Sequence Number: 14280959
• Product Code: JXG
• UDI-Device Identifier: 04041906135799
• UDI-Public: 4041906135799
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 12/31/2020
• Device Model Number: FV494T
• Device Catalogue Number: FV494T
• Device Lot Number: 20029060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: 8 YR