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

Model Number	FX602T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx602t) 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 (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: 70 centimeters (cm).Weight: (b)(6).Gender: female.
Additional Manufacturer Narrative
Investigations: visual inspection: no significant deformations or damage of the valve, but during the inspection visible deposits were detected on the deflector and in the control reservoir.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.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, no deposits were found in both valves.Results: based on our investigation, we are unable to substantiate the clinical claim of under-drainage.At the time of our investigation, the valves were operating within the specified tolerances.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from (b)(4) kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & CONTROL RES.
• 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: 13444928
• Report Number: 3004721439-2022-00007
• Device Sequence Number: 2110861
• Product Code: JXG
• UDI-Device Identifier: 04041906503222
• UDI-Public: 4041906503222
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: FX602T
• Device Catalogue Number: FX602T
• Device Lot Number: 20055564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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: 1 YR
• Patient Sex: Female
• Patient Weight: 7 KG