Events

Retiro De Equipo (Recall) de Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore

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 AngioScore Inc..

¿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
    54687
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2218-2010
  • Fecha de inicio del evento
    2009-12-04
  • Fecha de publicación del evento
    2010-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89016
  • 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 transluminal coronary angioplasty (ptca), cutting/scoring - Product Code NWX
  • Causa
    Separations of the ptca catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
  • Acción
    AngioScore sent an "Urgent: Medical Device Voluntary Recall" dated December 4, 2009 addressed to "Catheterization Lab Manager" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.

Device

Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore
  • Modelo / Serial
    Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. || Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.
  • Manufacturer
    AngioScore Inc.

Manufacturer

AngioScore Inc.
  • Dirección del fabricante
    AngioScore Inc., 5055 Brandin Ct, Fremont CA 94538-3140
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA