Events

Rappel de IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation Catheters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific Pty Ltd.

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
    RC-2015-RN-01156-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01156-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Boston scientific has received reports of bent distal tips, and in four cases, this situation resulted in exposed internal wires in the asymmetric curve models (known as n4) of intellatip mifi xp. the most common clinical observation is prolongation of the procedure to exchange a bent catheter with a new device. though no serious patient harms have been reported, a bent catheter tip or exposed internal wire could result in tissue damage to blood vessels and cardiac structures. this may result in cardiac or vascular perforation, with need for invasive intervention to prevent permanent damage or impairment.
  • Action
    Boston Scientific are advising users to inspect and quarantine any affected stock and return it to Boston Scientific. This action has been closed-out on 26/08/2016.

Device

IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation Catheters
  • Modèle / numéro de série
    IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation CathetersMaterial Numbers: M004EPM4500N40, M004EPM4790N40, M004PM4500N40 and M004PM4790N40Multiple Lot Numbers affectedARTG Number: 232994
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA