MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 35 & BURRHOLE RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX567T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx576t) was implanted during a procedure performed in (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in underdrainage and the complainant suspects a partial obstruction of the perforations in the ventricular catheter.The patient underwent a revision procedure on (b)(6) 2022.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: 170 centimeters (cm), weight: 80 kilograms (kg), gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: visible deposits in the perforation of the ventricular catheter, dried bloody deposits on the outside of the shunt system, deposits in the reservoir.Permeability test: a permeability test has shown that the progav 2.0 shunt system, the sprung reservoir and the ventricular catheter 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 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 klick force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid or blood.Despite this we have tested the device to the best of our abilities.For the sake of thoroughness and transparency, we would like to point out that a permeability test is already carried out after the revision at the hospital.Based on our examination results, we can determine deposits in both valves and in the perforations of the ventricular catheter.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.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 SYS SA2.0 35 & BURRHOLE 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: 14323255
• Report Number: 3004721439-2022-00123
• Device Sequence Number: 4660689
• Product Code: JXG
• UDI-Device Identifier: 04041906502522
• UDI-Public: 4041906502522
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: FX567T
• Device Catalogue Number: FX567T
• Device Lot Number: 20056417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 80 KG