Events

Retiro De Equipo (Recall) de The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature.

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Boston Scientific Corporation.

¿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
    76955
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1922-2017
  • Fecha de inicio del evento
    2017-04-05
  • Fecha de publicación del evento
    2017-04-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154677
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Peripheral, Atherectomy - Product Code MCW
  • Causa
    Boston scientific is initiating a voluntary removal of two lots of jetstream sc 1.85mm and one lot of jetstream xc 2.1mm atherectomy catheters due to these units being mislabeled. some 1.85mm jetstream sc catheters may have been labeled as 2.1mm catheters, and some 2.1mm jetstream xc catheters may have been labeled as 1.85mm catheters.
  • Acción
    Consignees were sent a Boston Scientific "Urgent Medical Device Removal" letter dated April 5, 2017. The letter was addressed to Materials Manager / Field Action Contact. The letter described the issue and the prduct involved in the recall. Advised consignees to segregate and return the affected product to Boston Scintific. This recall is to be carried to the customer level. Requested consginees to complete and return the Account Reply Verification Tracking Form. Contact your local Sales Representative can answer any questions that you may have regarding this Removal.

Device

The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treat...
  • Modelo / Serial
    18775553, 18775552, 18822086
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI. OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS
  • Descripción del producto
    The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 2 Scimed Pl, Maple Grove MN 55311-1565
  • 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
    USFDA