Events

Rappel de Device Recall EZ Steer ThermoCool Nav

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biosense Webster, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0981-2012
  • Date de mise en oeuvre de l'événement
    2010-11-22
  • Date de publication de l'événement
    2012-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106359
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
  • Cause
    Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter: 1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. to minimize risk of atrio-esophageal fist.
  • Action
    Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 909-839-8604.

Device

Device Recall EZ Steer ThermoCool Nav
  • Modèle / numéro de série
    Lot Numbers: 15076036, 15076035, 15059708, 14113238, 14105865, and 13439370
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA