Events

Avis De Sécurité sur PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Biosense Webster.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-05-05
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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