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	10/28/2022
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 (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure performed 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: 32 years, height: 170 centimeters (cm), weight: 70 kilograms (kg), gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: external and internal deposits on the control reservoir.Deposits in the inlet spout of shuntassistant 2.Permeability test: the investigation showed that the progav 2.0 shunt system was not permeable.In order to verify which of the components led to a blockage, the shunt system was separated and the components were tested individually for permeability tested.The investigation determined that the progav 2.0, the control reservoir, the peritoneal catheter and the ventricular catheter were permeable.The shuntassistant 2.0 showed no outflow.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 test bench measurement could only be performed to progav 2.0 due to the blockage detected of the shuntassistant 2.0, described under point 2.5 permeability test.The test bench measurement showed that the progav 2.0 operated in the reference flow range of 20 ml/h in the horizontal position of the valve with a value of 4.10 cmh2o within the specified tolerance (specified tolerance 6.5 cmh2o ± 3 cmh2o).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 both valves.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine a blockage in the shuntassistant 2.0 at the time of our investigation.The deposits found can be named as the cause of the blockage.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects 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 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: 15895460
• Report Number: 3004721439-2022-00361
• Device Sequence Number: 6700015
• 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 Implanted Year: 2022
• 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): 12/01/2022

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: 20059526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 70 KG