Events

Alerte De Sécurité sur IntellaTip Mifi XP Temperature Ablation Catheter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-05-21
  • Date de publication de l'événement
    2014-05-21
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140521.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: boston scientific intellatip mifi xp temperature ablation catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning certain lots of the intellatip mifi xp temperature ablation catheter. the affected catalogue numbers are pm4500, pm4500k2, pm4500n4, pm4790, pm4790k2 and pm4790n4. an investigation has found that some of the units manufactured from 14 august 2013 to 16 january 2014 were not manufactured according to specification. although this issue will typically result in an error code on the maestro 3000 cadiac ablation system, under certain conditions or in the event of an error code override, this manufacturing issue may result in excessive radio frequency energy being delivered to the myocardium. to date, the manufacturer has received five complaints related to this issue and none of these complaints reported injury. the potential health hazards associated with the delivery of excessive radio frequency energy include myocardial perforation and cardiac tamponade, as well as char formation on the catheter tip, which may result in embolic injury. the manufacturer advises users not to use the affected products and these products should be returned. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2014.

Device

IntellaTip Mifi XP Temperature Ablation Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific IntellaTip Mifi XP Temperature Ablation Catheter
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH