Events

Alerte De Sécurité sur recovery system

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Micro Therapeutics, 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
  • ID de l'événement
    R1611-484
  • Numéro de l'événement
    2011DM-0007727 ; 2014DM-0011189 ; 2010DM-0006683
  • Date
    2016-10-21
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=117
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that it has detected a problem in the coating of ptfe (polytetrafluoroethylene), which could be removed and detached from the access cable, the resulting particles could be introduced into the bloodstream, leading to potentially adverse events occur on patients.

Device

recovery system
  • Modèle / numéro de série
    Hydrophilic microguide mod X-CELERATOR 0.010 "300cm, Hydrophilic microguide mod X-CELERATOR 0.014" 300cm, || MARATHON 1.5F / 2.7F microcatheter 165cm guide 0.010 "|| 25cm, ALLIGATOR recovery system 2mm 175cm || OD 0.40mm, ALLIGATOR recovery system 3mm || 175cm OD 0.40mm, ALLIGATOR RETRIEVALDEVICE. 4mm, || all batches with Expiration date between June 2017 and || August 2019.
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Recovery of foreign bodies from the peripheral vasculature and the neurovascular system
  • Manufacturer
    Micro Therapeutics, Inc.

Manufacturer

Micro Therapeutics, 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
    NIDFSINVIMA