MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA30 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX436T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -no defects or other abnormalities are detected.Permeability test: the test showed that the progav 2.0 is permeable.Computer control test: the computer controlled test has shown the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position, to be 18.21 cmh2o.This is within the specified tolerance of 20 cmh2o ± 3 cmh2o.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 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, no deposits were found in progav 2.0.Results: based on our investigation, we are not able to substantiate the claim of "blockage".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.The valve showed no deviations of the specifications during the test.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.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 2.0 valve.The surgeon suspected a dysfunction/blockage of the valve.Patient informations: (b)(6).

• Brand Name: PROGAV 2.0 SYS W/SA30 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11280521
• Report Number: 3004721439-2021-00011
• Device Sequence Number: 4170440
• Product Code: JXG
• UDI-Device Identifier: 04041906137342
• UDI-Public: 4041906137342
• 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: 2021
• 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): 02/04/2021

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: 04/09/2023
• Device Model Number: FX436T
• Device Catalogue Number: FX436T
• Device Lot Number: 20037634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/04/2021
• 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: 51 YR