Events

Alerte De Sécurité sur Nit-Occlud Implantation Sheath

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

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
    2017-11-21
  • Date de publication de l'événement
    2017-11-21
  • 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_20171121.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: pfm medical nit-occlud implantation sheath the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has posted a medical device safety alert concerning nit-occlud implantation sheath, manufactured by pfm medical ag. the affected devices are identified as follows:- product names: a) implantation sheath, 10f, 45°, 80cm; b) implantation sheath, 12f, 45°, 80cm; c) implantation sheath, 12f, 45°,80cm; d) implantation sheath, 14f, 45°, 80cm; e) implantation sheath, 6f, 45°, 80cm; f) implantation sheath, 8f, 45°, 80cm; g) implantation sheath, 9f, 45°, 80cm reference numbers: a) 004580; b) 204580; c) 204580; d) 404580; e) 604580; f) 804580; g) 904580 the manufacturer has received feedback from the outside european community that in individual cases the atraumatic tip (soft tip) of the nit-occlud implantation sheath detached during preparation and application under incorrect storage conditions (discoloration of the sterile packaging). according to the manufacturer, the sheaths are being used to get access to the vessel system. particles from the tip of the sheath therefore might embolize in the vessel system and as a result impede or stop the blood flow. particles in the venous system could cause a pulmonary embolism or thrombosis. embolizing particles in the arterial system could possibly result in infarction on all organ systems with tissue death (necrosis) and could result in heart attack and stroke. this can in the worst case lead to irreversible organ damage up to death the manufacturer has not received any information so far that the products have quality problems when properly stored and used. however, due to the high potential risk of detachment, the manufacturer decided to recall the affected devices as a precaution in order to investigate them systematically. for further details including the affected lot numbers, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-13-to-17-november-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 november 2017.

Device

Nit-Occlud Implantation Sheath
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: PFM Medical Nit-Occlud Implantation Sheath
  • Manufacturer
    PFM Medical AG

Manufacturer

PFM Medical AG