Events

Alerte De Sécurité sur Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation 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
    2014-02-06
  • Date de publication de l'événement
    2014-02-06
  • 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_20140206.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 coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter. the manufacturer is initiating a recall removal of one lot of the coyote over-the-wire pta balloon dilatation catheter [catalog no.: 39186-25121; lot 16397693] and one lot of the coyote monorail pta balloon dilatation catheter [catalog no.: 39185-20151; lot 16310947]. the manufacturer has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. to date, the manufacturer has received three complaints for this issue. according to the manufacturer, the most common adverse health consequences resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. the manufacturer instructs all affected users to cease immediately further distribution or use of any remaining product affected by this medical device safety alert. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2014.

Device

Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation 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