Events

Alerte De Sécurité sur THERMOCOOL SMARTTOUCH Catheter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Biosense Webster.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-10-23
  • Date de publication de l'événement
    2014-10-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141023a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biosense webster thermocool smarttouch catheter medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its thermocool smarttouch catheter family [catalogue number: d132701, d132702, d132703, d132704, d132705, d133601, d133602, d133603; lot number: all]. biosense webster, a division of johnson & johnson medical nv/sa has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the thermocoolsmarttouch catheter during the time period of january 2012 to july 2014. none of the reported complaints were associated with any adverse events. through the investigation, manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. the manufacturer would like to reinforce the following statements from the warnings and precautions and directions for use in the instructions for use (ifu) for the thermocool smarttouch catheter family: warnings and precautions: do not use excessive force to advance or withdraw the catheter when resistance is encountered. directions for use: to verify compatibility between the sheath and catheter, advance the catheter through the sheath prior to insertion. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 october 2014.

Device

THERMOCOOL SMARTTOUCH Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webster THERMOCOOL SMARTTOUCH Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster