Events

Retiro De Equipo (Recall) de PORTOSYSTEMIC SHUNT INTRODUCER SETS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOK (CANADA) 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
    63110
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-04-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    There is an increase in reports of polymer degradation of the catheter tip resulting in tip fracture and/or separation. environmental conditions such as storage temperature humidity and the use of vaporized hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities may be contributing to the occurrence. there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function separation of a device segment leading to medical intervention or complications resulting from a separated segment. such complications include device fragments in the vascular system genitourinary system or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs or occluding blood flow to end organs.

Device

PORTOSYSTEMIC SHUNT INTRODUCER SETS
  • Modelo / Serial
    Model Catalog: TIPSS-200 (Lot serial: > 10 SERIAL #'S CONTACT MFR); Model Catalog: TIPSS-100 (Lot serial: ALL); Model Catalog: TIPSS-200 (Lot serial: ALL); Model Catalog: TIPSS-100 (Lot serial: > 10 SERIAL #'S CONTACT MFR)
  • Descripción del producto
    TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE PACK
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.