Events

Retiro De Equipo (Recall) de ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)

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-2015-RN-01192-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-07
  • 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-2015-RN-01192-1
  • 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
    Boston scientific is recalling certain lots of 9fr acuity pro coronary sinus outer guide catheters due to potential for separation of the proximal handle from the shaft. boston scientific's investigation concluded that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. the affected products were manufactured during the time period when the equipment was likely to be misaligned.The most serious injury foreseeable with unexpected hub detachment is a moderate delay in the procedure to reposition a dislodged lead. boston scientific has received reports of handle separations during the cut and removal process; there have been no reports of patient harm.
  • Acción
    Customers are advised to immediately segregate all affected products to ensure that it will not be used and to ship the stock back to Boston Scientific for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a...
  • Modelo / Serial
    ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)Model Numbers: 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119Multiple Lot Numbers affectedARTG Number: 222220
  • 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