Events

Alerte De Sécurité sur Symplicity Catheters

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 Ltd..

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
    2013-01-28
  • Date de publication de l'événement
    2013-01-28
  • 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_20130128.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 symplicity catheters medical device manufacturer, medtronic ltd., has issued a field safety notice concerning symplicity catheters. the affected model numbers are iderdn006 and rdn006. the manufacturer has observed a connection issue complaint rate of approximately 5% of devices provided since enrollment of the symplicity htn3 trial began. these connection issues cause unstable temperature readings or lack of signal to the generator. in events where a connection failure leads to unstable temperature reading, the generator’s safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment, thus in either situation protecting the patient from unsafe treatment. these connection issues manifest in one of the following ways: a flickering generator display screen upon initial catheter connection generator status display of “check connection” rapid fluctuations in the temperature reading multiple early termination of energy delivery accompanied by “check status” safety codes 22, 23 and/or 32 despite confirming electrode placement as defined by the ifu. the result of these connection failures is the potential need during the procedure to replace the catheter to successfully complete the renal denervation procedure. the manufacturer advises users to connect the catheter into the generator prior to inserting into the patient according to the ifu. furthermore, the manufacturer advises users that if observing any of the conditions above, they should follow the steps below: assure the catheter connector plug is fully seated into the generator by unplugging and re-plugging the catheter. if this resolves the issue, continue with treatment. gently wiggle the connector plug. if this resolves the issue, continue with treatment. if the issue remains, replace the catheter and return the catheter to medtronic for investigation. medtronic has also developed a new catheter connector. according to the local supplier, medtronic international limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 january 2013.

Device

Symplicity Catheters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Symplicity Catheters
  • Manufacturer
    Medtronic Ltd.

Manufacturer

Medtronic Ltd.
  • 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