Events

Retiro De Equipo (Recall) de Device Recall Boston Scientific Platinum Plus Guidewire

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
    49001
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2364-2008
  • Fecha de inicio del evento
    2008-06-19
  • Fecha de publicación del evento
    2008-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72496
  • 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
    Guidewire - Product Code DQX
  • Causa
    Boston scientific is initiating a voluntary recall of the platinum plus coronary guidewire. through our internal inspection process, we identified the potential that the ptfe (polytetrafluoroethylene) coating on the platinum plus coronary guidewires could be damaged in certain locations. this damage of the coating creates the potential for small particles of the ptfe coating to detach from the wi.
  • Acción
    An urgent Voluntary medical Device Recall or Correction - Immediate Action Required letter was sent to all affected customers. The letter describes the issue and clinical effects. A list of affected devices is attached to the letter. The customer is to cease use or distribution of affected product, and return it immediately to Boston Scientific. Return directions are provided in an attached document. A Reply Verification Tracking Form is to be completed and faxed back to Customer Service. If any product is being returned the completed form is to accompany the returned product. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.

Device

Device Recall Boston Scientific Platinum Plus Guidewire
  • Modelo / Serial
    Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Descripción del producto
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 1 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