Events

Retiro De Equipo (Recall) de Vessix Generator System (portable RF generator used with percutaneous angioplasty balloon catheter to deliever low frequency RF energy into the renal artery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-01213-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01213-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    An investigation has found that the units manufactured since april 2013 were not manufactured according to specification. this manufacturing issue may cause an electrical short in the generator. the issue could result in excessive rf energy being delivered to the renal artery with intermittent temperature spikes that may range between 86 - 93 degrees c.
  • Acción
    Customers are requested to segregate the devices immediately and organise for the return to Boston Scientific.

Device

Vessix Generator System (portable RF generator used with percutaneous angioplasty balloon cathete...
  • Modelo / Serial
    Vessix Generator System (portable RF generator used with percutaneous angioplasty balloon catheter to deliever low frequency RF energy into the renal artery)Material Number: H749RDNS0100Catalogue Number: RDNS010Serial Numbers: 42041, 42020, 42011, 42034, 42042, 42035ARTG Number: 208743
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA