MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 15 U.PAED.CONTR.RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX557T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/14/2022
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 october 2019.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 stage of 15 cmh2o.The shunt system was inspected as article fx557t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has shown that the valve is permeable.Adjustment test the progav® 2.0 was tested and is not adjustable throughout the normal range.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.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 valve is tested in the horizontal positions.The results show that the valve operates within the accepted tolerance.Internal inspection after dismantling of the valves, deposits were found in progav® 2.0 and in the shuntassistant® 2.0.Result: for the sake of thoroughness and transparency, we would like to point out that a permeability and a adjustability test was already carried out after the revision at the hospital.Existing deposits in the csf can temporarily impair the function of the valves and is described as concomitant symptoms in hydrocephalus therapy.Based on our examination results, we can detect deposits.The deposits do not affect the technical properties at the time of the examination.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.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 # fx557t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system was believed to be operated in overdrainage.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 years, 3 months, height: 82.5 centimeters (cm), weight:10 kilograms (kg), gender: female.

• Brand Name: PROGAV 2.0 SYS SA2.0 15 U.PAED.CONTR.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: 15629187
• Report Number: 3004721439-2022-00312
• Device Sequence Number: 7941648
• Product Code: JXG
• UDI-Device Identifier: 04041906503659
• UDI-Public: 4041906503659
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 10/06/2024
• Device Model Number: FX557T
• Device Catalogue Number: FX557T
• Device Lot Number: 20044081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• 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: 27 MO
• Patient Sex: Female
• Patient Weight: 10 KG