Events

Alerte De Sécurité sur Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation 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 Medtronic.

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
    2015-10-26
  • Date de publication de l'événement
    2015-10-26
  • 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_20151026.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: medtronic amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter medical device manufacturer, medtronic, has issued a medical device safety alert concerning its amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter. the affected products are identified as follow: model number:amd015020002, amd020120152, amd025150152, amd030150152, amd040120002, amd335210002, amd015020151, amd020150002, amd030040002, amd035040152, amd040120152, amd335210152, amd015020152, amd020150152, amd030040152, amd035120002, amd040150002, amd354210002, amd020040002, amd025040152, amd030080002, amd035150002, amd040150152, amd354210152, amd020040152, amd025080152, amd030080152, amd035150152, amd225210002, amd020080002, amd025120002, amd030120002, amd040040152, amd225210152, amd020080152, amd025120152, amd030120152, amd040080002, amd253210002, amd020120002, amd025150002, amd030150002, amd040080152, amd253210152 medtronic is conducting a voluntary urgent medical device recall of the affected products due to a potential breach of pouch seal for the product manufactured in select lots. according to the manufacturer, they did not receive any customer complaint or report of adverse patient events regarding improperly sealed pouches. the potential for the breach in the pouch enclosing the sterilized product was discovered during internal packaging testing, which involved exposure to extreme use conditions. the manufacturer requests the customers to identify and quarantine all unused, affected product in their inventory, and return them to the manufacturer. patients who have received treatment with the devices affected by the recall should continue to be monitored in accordance with the physician’s standard practice. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 october 2015.

Device

Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH