Events

Alerte De Sécurité sur CoreValve AccuTrak Delivery Catheter System

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

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
    2013-11-28
  • Date de publication de l'événement
    2013-11-28
  • 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_20131128a.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: medtronic corevalve accutrak delivery catheter system medical device manufacturer, medtronic inc has issued a medical device safety alert concerning corevalve accutrak delivery catheter system (dcs). models dcs-c4-18fr and dcs-c4-18fr-23 are affected. as of 31 october 2013, medtronic has received 38 reported nose cone separation events (0.08 percent of implant procedures). 5 of these reported events (0.01 percent of implant procedures) led to the need for surgical intervention. a thorough review and investigation of the reported events has identified that a majority of these reported events occurred in situations cautioned against in current labeling. in addition, medtronic has determined that the following situations can lead to nose cone separations: using the corevalve accutrak dcs to retrieve (remove) a partially deployed valve. removing the corevalve accutrak dcs from the patient, after valve deployment, without fully closing the corevalve accutrak dcs capsule. continuing to pull on the corevalve accutrak dcs if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during corevalve accutrak dcs retrieval. to reduce the occurrence of nose cone separations, medtronic is modifying the instructions for use and training materials for corevalve accutrak dcs models dcs-c4-18fr and dcs-c4-18fr-23. meanwhile, users are advised to consider the following recommendations during the corevalve implant procedure: while the dcs is in the patient, ensure the guidewire is extending from the nose cone, and do not remove the guidewire from the catheter while the catheter is inserted in the patient. once deployment is initiated, retrieval (removal) of the bioprosthesis from the patient is not recommended. partial repositioning, if needed, should be followed per the ifu guidance. before dcs removal, ensure the capsule is closed. if the capsule does not close properly, gently rotate the catheter clockwise (<180°) and then counterclockwise (<180°) until the capsule closes. if there is increased resistance when removing the dcs through the introducer sheath, do not force passage as increased resistance may indicate a problem and may result in damage to the device and/or harm to the patient. if the cause of resistance cannot be determined or corrected, remove the catheter and introducer sheath as a single unit over the guidewire, and inspect the catheter. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 november 2013.

Device

CoreValve AccuTrak Delivery Catheter System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic CoreValve AccuTrak Delivery Catheter System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH