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

Model Number FV701T

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Height: 175 cm: date of implantation: 2017 (month and day unknown).Investigation: 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 the presence of a deformation.The housing deformation measured at -0.0915 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the prosa valve is permeable.Adjustment test: the prosa valve was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.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.Next, we tested the permeability, adjustability as well as the brake functionality and brake force.The prosa valve was permeable but could not be adjusted to all settings.Finally, we have dismantled the valve.Inside the valve we have found slightly build-up of substances (likely protein.Based on our investigation, we confirm that the prosa valve was non-adjustable at the time of our investigation.The cause of the deformation of the prosa valve and the resultant defect of the rotor 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 (b)(4).

Event Description

It was reported that a valve is not adjustable.The reporter indicated that a 2 year 4 month post operative valve is not adjusting.The device was explanted.Additional event details have not been provided.

• Brand Name: PROSA VALVE
• 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: 9507824
• MDR Text Key: 188562414
• Report Number: 3004721439-2019-00289
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20029898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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: 79 YR
• Patient Weight: 90