Events

Alerte De Sécurité sur Diamondback 360 Peripheral Orbital Atherectomy 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 Cardiovascular Systems.

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
    2014-08-20
  • Date de publication de l'événement
    2014-08-20
  • 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_20140820b.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: cardiovascular systems, inc. diamondback 360 peripheral orbital atherectomy system the united states food and drug administration (fda) has issued a medical device safety alert concerning diamondback 360 peripheral orbital atherectomy system [model number: dpb-125micro145; part number: 7-10003; lot numbers: 100573, 100575, 100674, 100676, 100678, 100680], manufactured by cardiovascular systems, inc. ninety-four affected devices were manufactured from 05/08/2014 to 05/09/2014. forty-eight devices were distributed from 05/16/2014 to 05/20/2014. according to the fda, the manufacturer is recalling certain lots of the diamondback 360 peripheral orbital atherectomy systems because they may contain defective saline sheaths that could fracture during use. if this happens, fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism). there are no reported patient injuries to date. on may 27, 2014, the manufacturer sent an “urgent medical device recall” letter to their customers. the letter identified the problem and the specific products affected by the recall. the letter advises customers to: remove affected devices from service. complete and return a “customer acknowledgement form.” return affected devices to cardiovascular systems. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm410527.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm410449.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2014.

Device

Diamondback 360 Peripheral Orbital Atherectomy System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Cardiovascular Systems, Inc. Diamondback 360 Peripheral Orbital Atherectomy System
  • Manufacturer
    Cardiovascular Systems

Manufacturer

Cardiovascular Systems