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

Model Number FX991T

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/03/2019

Event Type  Injury  

Manufacturer Narrative

Visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed/indicated the presence of a deformation.The housing deformation measured at -0.0595 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the prosa shunt system is permeable.Adjustment test: the prosa valve and the progav 2.0 valve were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test by both valves has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: first, we performed a visual inspection of the prosa shunt system.A deformation of the outer housing of the prosa valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plan parallelity.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The prosa and the progav 2.0 valve operates as expected and met all specifications.Finally, we have dismantled the valves.There were no visible deposits observed inside the prosa valve, inside the progav 2.0 are minimal visible deposits.Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the prosa shunt system was shown to be permeable.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.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.

Event Description

It was reported that a valve is blocked.The reporter indicated that a 2 year 5 month post operative is blocked and required explantation.Additional event details have not been provided.A request for additional information has been made, however, not yet received.

• Brand Name: PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9409410
• MDR Text Key: 169243835
• Report Number: 3004721439-2019-00282
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20034719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 85