Events

Field Safety Notices about PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Biosense Webster.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-05-05
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    At biosense webster, we are committed to ensuring patient safety, so we are constantly monitoring the performance of our products to meet our customers' expectations. biosense webster would like to further clarify the record of contraindications in the package leaflet and on the product labels of this catheter regarding patients with prosthetic flaps. an existing record in the instructions for use warns against using the pentaray® catheter on prosthetic flap patients, which states in the contraindication paragraph: “this catheter may not be suitable for use on prosthetic flap patients.” the package leaflet has been updated for additional clarification a contraindication record that now reads: "do not use pentaray® catheters on patients with prosthetic flaps".

Device

PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters

Manufacturer

Biosense Webster