MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX991T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa shunt system (#fx991t) was implanted during a procedure performed (b)(6) 2017.According to the complainant, the shunt system was believed to be operated in overdrainage and difficult to adjust.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: 56 years, height: 180 centimeters (cm), weight: 100 kilograms (kg), gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: scratches and a deformation of the outer housing of the prosa valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,049mm the housing membrane is outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of over-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.The prosa was not adjustable.Braking force and brake function test: the brake functionality test of the progav 2.0 has shown that the brake function is fully operational and the braking force is within the given tolerances.The brake function of the prosa is operational, however the braking force cannot be measured due to the non-adjustability of the valve.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 : for the sake of completeness and transparency, we would like to point out that a permeability test was already performed at the hospital after the revision.Based on our examination results, we can confirm a non-adjustability and a deformation of the outer housing of the prosa.As causes for the non-adjustability, the determined deformation of the outer housing and the deposits can be named.Excessive pressure from the adjustment pin or a hit to the patient's head can compromise the integrity of the valve.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: PROSA SYS W/PROGAV 2.0 A.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: 16099058
• Report Number: 3004721439-2022-00408
• Device Sequence Number: 17774450
• Product Code: JXG
• UDI-Device Identifier: 04041906138493
• UDI-Public: 4041906138493
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/04/2023

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: 10/11/2022
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20035363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2017
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 100 KG