MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX490T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (part # fx490t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was found to be occluded on (b)(6) 2023.The paitent underwent a revision procedure on (b)(6) 2023.The complaint device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Shoud relevant additional iinfornation/investigation results became available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: - deposits on the housing - piece of third-party catheter at the outlet permeability test: the test showed that the progav 2.0 is permeable.Computer control test: the computer control test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 5.96 cmh2o.This is not within the specified tolerance of 10.5 ± 3 cmh2o.According to our results, we can detect an accelerated outflow.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, the valve is finally opened with a special tool.After dismantling of the valve, deposits were found in progav 2.0.For more detailed visibility, the proteins/deposits in progav 2.0 were colored by using a coloring solution.Results: based on our investigation results, we have determined that there was a slower outflow in the valve at the time of our investigation.The cause of the accelerated outflow are the detected deposits in the valve.Endogenous substances in the cerebrospinal fluid can 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 met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR
• 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: 16856614
• Report Number: 3004721439-2023-00123
• Device Sequence Number: 12455287
• Product Code: JXG
• UDI-Device Identifier: 04041906137786
• UDI-Public: 4041906137786
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: FX490T
• Device Catalogue Number: FX490T
• Device Lot Number: 20059801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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: 9 MO
• Patient Sex: Unknown