Events

Retiro De Equipo (Recall) de Device Recall IntellaTip MiFi XP Asymmetric Curve Temperature Ablation Catheter

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 Corp.

¿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
    72721
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0462-2016
  • Fecha de inicio del evento
    2015-11-20
  • 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=142030
  • 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, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Causa
    During routine monitoring of complaints, bsc noted that the intellatip mifi xp n4 complaint rate for distal tip bends/kinks was above the anticipated rate in bsc's product risk documentation.
  • Acción
    Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.

Device

Device Recall IntellaTip MiFi XP Asymmetric Curve Temperature Ablation Catheter
  • Modelo / Serial
    Material Number: M004EPM4500N40;  Catalog number: EPM4500N4; Lot numbers: 16743760, 17135083, 17614450, 18140623, 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.
  • Descripción del producto
    IntellaTip MiFi XP Asymmetric (N4) Curve, || 7/110/2.5/8-8 OUS; || Material Number: M004EPM4500N40; Catalog number: EPM4500N4; || Cardiac: || The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Dirección del fabricante
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 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