MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA2.0 25 A..DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX649T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® 2.0 shunt system was manufactured by a qualified employee in july 2021.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav® 2.0 shunt system is comprised of a progav® 2.0 adjustable pressure valve with a normal pressure range of 0 to 20 cmh2o and a shuntassistant® 2.0 fixed pressure valve with a fixed pressure range of 25 cmh2o.The shunt system was inspected as article fx649t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: bloody deposits were discovered on the inlet spout of the progav 2.0.Pic.1: progav® 2.0 with visible deposits.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the shuntassistant® 2.Is operating within the accepted tolerance in the horizontal position.The progav® 2.0 is operating not within the specified tolerances in the vertical position.Adjustment test: the progav® 2.0 was tested and is adjustable to all specified pressures.Braking/klick force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, some deposits were found in both valves.Results: based on our investigation, we confirm that the valve shows an increased flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx649t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be underdrained and was unable to adjust.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: (b)(6), gender: female.

• Brand Name: PROGAV 2.0 WITH SA2.0 25 A..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: 13546219
• Report Number: 3004721439-2022-00022
• Device Sequence Number: 20137685
• Product Code: JXG
• UDI-Device Identifier: 04041906502072
• UDI-Public: 4041906502072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/16/2022

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: 07/04/2026
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20053910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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: 35 MO
• Patient Sex: Female