Events

Retiro De Equipo (Recall) de Device Recall Intella Tip MiFi Open Irrigated 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
    70506
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1209-2015
  • Fecha de inicio del evento
    2015-02-03
  • Fecha de publicación del evento
    2015-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133925
  • 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
    Reports of formation of char adherent to the proximal part of the distal tip electrodes.
  • Acción
    Customer notification letters were sent by overnight mail on February 10, 2015.

Device

Device Recall Intella Tip MiFi Open Irrigated Ablation Catheter
  • Modelo / Serial
    Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879.  Material number: M004EPM9620K20, Catalog Number: EPM9620K2: Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714.  Material number : M004EPM9620N40; Catalog number: EPM9620N4; Serial numbers: 17148152, 17226126, 17266642.  All with Expiry Dates of April 20, 2015 - June 14, 2015.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distributed in Germany, Great Britain, and the Netherlands.
  • Descripción del producto
    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: || Material number: M004EPM96200, Catalog Number: EPM9620: || Material number: M004EPM9620K20, Catalog Number: EPM9620K2; || Material number : M004EPM9620N40; Catalog number: EPM9620N4. || The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation || The product is not approved for use/sale in the US.
  • 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