Events

Retiro De Equipo (Recall) de Cordis S.M.A.R.T. Flex Vascular Stent System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cardinal Health Australia 503 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-2017-RN-00259-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-24
  • 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-2017-RN-00259-1
  • 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
    Based on complaints, cordis has detected a higher frequency of users reporting difficulty with stent deployment of s.M.A.R.T. flex vascularstent system sizes 5x200mm and 6x200mm, compared to other sizes. inherently, longer stents have higher deployment forces, and the s.M.A.R.T.® flex vascular stent system 5x200mm and 6x200mm sizes have higher deployment forces than larger stent diameter sizes of the same length based on differences in the as-cut stent pattern. the most reported deployment difficulty is the inability to deploy the stent resulting in an intra-procedural delay while a replacement device is prepped. however, partial stent deployment may cause ischemia, or internal bleeding, which would require further intervention.
  • Acción
    Cordis is requesting customers to check their inventory immediately and quarantine affected stock. Customers are further advised to contact their local sales representative for the return of the affected stock for a product replacement or credit. (Please note that replacements of the same sizes are not currently available.)

Device

Cordis S.M.A.R.T. Flex Vascular Stent System
  • Modelo / Serial
    Cordis S.M.A.R.T. Flex Vascular Stent System Catalogue Numbers: SF05200SV and SF06200SVStent size and catheter length: 5 x 200mm, 80cmGTIN: 20705032066409 and 20705032067024Catalogue Numbers: SF05200MV and SF06200MVStent size and catheter length: 5 x 200mm, 120cmGTIN: 20705032066829 and 20705032066836All unexpired lots (Lot range 34469 through 39974)ARTG Number: 223910
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Cardinal Health Australia 503 Pty Ltd

Manufacturer

Cardinal Health Australia 503 Pty Ltd