Events

Alerte De Sécurité sur PHIL Liquid Embolic 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 Microvention Europe || Microvention 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
    R1608-359
  • Numéro de l'événement
    2015DM-0013279
  • Date
    2016-08-23
  • 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=124
  • 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 the possibility of dispersion of unwanted particles (metal) in the composition of the device, causing a discoloration of the embolic fluid, leading to its use may cause possible adverse events on patients.

Device

PHIL Liquid Embolic System
  • Modèle / numéro de série
    LEN10250, LEN10300 and LEN10350, lots 15062529 - 15102026 - 15102326 - 16040534 - 15052637 - 15092123 || - 16010528 - 1603142 - 15062539 - 15091029 - 16010637.
  • Description du dispositif
    The liquid embolic system (PHIL) is based on an organic solvent, dimethyl sulfoxide (DMSO). The agent is embolicoliquido in a co-polymer soluble in DMSO and insoluble in an aqueous medium. The iodine is linked to the copolymer as the radiopacifier component. The two components of the PHILL are preloaded in a syringe each, ready to use when leaving the package without the need for a preparation pass. The purpose of the PHILL is to be used in the embolization of peripheral lesions and deneurovasculature, including arteriovenous malformations and hypervascular tumors. In the treatment of neurovascular targets, achieve occlusion of blood flow to increase the ease of surgical resection and / or embolized abnormalities without resection. MVLES can be used together with other therapeutic agents and de-embolization, such as occlusion coils and balloons. Additionally, MVLES's viable applications are as an embolization device in cases of hemorrhagic occlusion and vessel sacrifice.
  • Manufacturer
    Microvention Europe || Microvention Inc.

Manufacturer

Microvention Europe || Microvention Inc.