MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FV701T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.The delivery liquid is bloody and protein particles are on the valve.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.054 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the prosa valve is permeable.Bloody liquid is drained.Adjustment test: the prosa valve 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 operates as expected.However, the breaking force required was not within the given specifications.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 prosa valve is operating within acceptable tolerances.Results: first, we performed a visual inspection of the prosa valve.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.Additional were protein deposits oft he valve and a bloody delivery liquid detected.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve operated as expected, however the brake force was outside of tolerance.All other specifications were met.Finally, we have dismantled the valve.Inside the valve we have found a strong bloody build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of under-drainage.At the time of our investigation, the opening pressure of the prosa valve was within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the 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 valve 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 Description

It was reported that there was a problem with a prosa valve.The surgeon suspected an underdrainage.Patient informations: age: (b)(6).Height: unknown.Weight: unknown.Gender: male.Implantation: (b)(6) 2019.Removal: (b)(6) 2020.

• Brand Name: PROSA VALVE
• Type of Device: 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: 11013450
• MDR Text Key: 223591282
• Report Number: 3004721439-2020-00251
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: 4041906133023
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20041242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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: 32 MO