Events

Alerte De Sécurité sur Archer 0.035 inch (0.89mm) Super Stiff Guidewire

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 Inc..

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
    2013-03-22
  • Date de publication de l'événement
    2013-03-22
  • 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_20130322a.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 archer 0.035 inch (0.89mm) super stiff guidewire medical device manufacturer,medtronic inc., has initiated a medical device field safety correction action concerning specific lot numbers of the medtronic archer 0.035 inch (0.89mm) super stiff guidewire, models arcsj200w, arcsj260w and arcdj260w. medtronic has identified an issue involving the affected products, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. as a result, medtronicis recalling the affected guidewires. as of 1 feb, 2013, medtronic has received 9 reports involving 14 guidewires related to this issue; 4 of these reports involved serious injury.There were no patient deaths and no additional reported clinical sequelae related to these reports. in hong kong, the local supplierhas not been aware of any adverse incident related to the above mentioned issue. based on these reports, the overall failure rate of affected guidewires is approximately 0.1% for the kinking or breaking in-vivo.Corrective actions to the manufacturing process have been taken to prevent recurrenceof this issue in subsequent production. the manufacturer advises that patients should continue to be managed in accordance with the standard patient management protocol andthe guidewireinstruction foruse. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 march 2013.

Device

Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 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