Events

Alerte De Sécurité sur Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERIPHERAL ANGIOPLASTY ANVISA Registration Number: 10349000474 Hazard Class: II Affected Model: AB18W030200150

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par AUTO SUTURE DO BRASIL LTDA; ev3 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
    2120
  • Date
    2016-08-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    There is no need for action with the patient. Patients who received treatment with an OTW Dilatation Catheter for 0.018 "PowerCross ™ PTA affected by this recall should continue to be monitored according to standard practice.
  • Cause
    Auto suture is conducting a voluntary recall of two lots of otw dilatation catheter for pta powercross ™ 0.018 ". this recall was initiated for model ab18w030200150 and is limited to lot numbers a213373 and a216702. this voluntary recall is being initiated due to the identification of a divergence in the description of the size of the balloon. where these affected units, which have a true size of the 3 x 200 mm balloon, are incorrectly marked on the product itself, specifically in the area of ​​tension relief, such as 2.5 x 150 mm (as shown in the enclosed customer letter ). the correct labeling (3 x 200 mm) for the actual size of the balloon is included in the outer carton as well as the inner packaging of the affected devices.
  • Action
    Field Action Code FA Recall PowerCross triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company will collect for further destruction.

Device

Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERI...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; ev3 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
    ANVSANVISA