MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 25 & CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX667T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # (b)(4)) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on an unknown date.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).Height: 130 centimeters (cm).Weight: (b)(6) (kg).Gender: male.
Additional Manufacturer Narrative
Investigations: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: the results show that the valves operate within the accepted tolerance in both positions.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking 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, deposits were found in progav 2.0.Results: for the sake of thoroughness and transparency, we would like to point out that an adjustment test and permeability test were already carried out after the revision at the hospital.Based on our examination results, we can determine deposits in the progav 2.0.The deposits do not affect the functional characteristics at the time of the examination.T the time of the examination, we are unable to determine how the mentioned functional impairment occurred.Existing deposits in the csf can temporarily 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 shunt system 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.

• Brand Name: PROGAV 2.0 W/SA2.0 25 & CONTROL RESERV.
• 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: 14112289
• Report Number: 3004721439-2022-00102
• Device Sequence Number: 13990195
• Product Code: JXG
• UDI-Device Identifier: 04041906503116
• UDI-Public: 4041906503116
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: 02/09/2025
• Device Model Number: FX667T
• Device Catalogue Number: FX667T
• Device Lot Number: 20045955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• 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 YR
• Patient Sex: Male
• Patient Weight: 20 KG