MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS PROGAV 2.0 & PED.SPRUNG RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX987T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.A measurement of the plane paralelism could confirm this.The housing deformation measured at -0.067 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the prosa and the progav 2.0 are permeable.Adjustment test: the prosa and the progav 2.0 valves were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test of both valves has shown that the brake function is fully operational and the braking force is within the given tolerances.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 results show that the prosa is not operating within the acceptable tolerance in vertical position.Furthermore the progav 2.0 is operating not within the acceptable tolerance in horizontal position.Internal inspection: after dismantling of the valves, deposits were found in prosa and progav 2.0.Results: based on our investigation, we determine an accelerated outflow in the shunt system at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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.
Event or Problem Description
It was reported that a prosa shuntsystem (part # fx987t) 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 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: 14 months, height: 68 centimeters (cm), weight: 7 kilograms (kg), gender: male.

• Brand Name: PROSA SYS PROGAV 2.0 & PED.SPRUNG 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: 15505700
• Report Number: 3004721439-2022-00291
• Device Sequence Number: 20155032
• Product Code: JXG
• UDI-Device Identifier: 04041906142292
• UDI-Public: 4041906142292
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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 Expiration Date: 11/09/2025
• Device Model Number: FX987T
• Device Catalogue Number: FX987T
• Device Lot Number: 20050611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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: 14 MO
• Patient Sex: Male
• Patient Weight: 7 KG