MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX666T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx666t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be operated in underdrainage.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: (b)(6).Height: 119 centimeters (cm).Weight: (b)(6).Gender: female.
Additional Manufacturer Narrative
Visual inspection: the following was detected during the visual inspection: bloody delivery fluid.Blood and deposits in the reservoir.Deposits on the catheters.Tissue residues at the inlet of the reservoir.Permeability test: a permeability test has shown that both valves with the reservoir are permeable.Computer controlled test: to investigate the claim of under-drainage, 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 valves operated 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, in the shuntassistant 2.0 were no visible deposits.Results: based on our examination results, we can determine deposits in the progav 2.0 and in the control reservoir.The deposits do not affect the functional characteristics at the time of the examination.At the time of the examination, we are unable to determine how the mentioned functional impairment occurred.Proteins /deposits in the csf can temporarily impair the function of the valves 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 (b)(4).No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & 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: 14091652
• Report Number: 3004721439-2022-00099
• Device Sequence Number: 4908364
• Product Code: JXG
• UDI-Device Identifier: 04041906503109
• UDI-Public: 4041906503109
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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 Model Number: FX666T
• Device Catalogue Number: FX666T
• Device Lot Number: 20055533
• 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: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 37 KG