Events

Alerte De Sécurité sur Twin-Pass, Twin-Pass RX and Twin-Pass .023" 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 Vascular Solutions.

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
    2016-09-21
  • Date de publication de l'événement
    2016-09-21
  • 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_20160921.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: vascular solutions twin-pass, twin-pass rx and twin-pass .023" catheters medical device manufacturer, vascular solutions, inc., has issued a medical device safety alert concerning its twin-pass, twin-pass rx and twin-pass .023" catheters. [model numbers: 5200, 5210, 5230; lot numbers: 575653, 577278, 577279, 577761, 577762, 578419, 578996, 578997, 579472, 5797s7, 580186, 580612, 580613, 581252, 582138, 582579, 582580, 583021, 583785, 584155, 584156, 584463, 584812, 585176, 585784, 585785, 586310, 586399, 587030, 587407, 587772, 588499, 588542, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 590739, 591037, 591261, 591262, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593696, 593717, 593985, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037]. the manufacturer has become aware of a potential problem with their twin-pass (5200), twin-pass rx (5210) and twin-pass .023” (5230) dual access catheters. investigation concluded that there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure, which poses a potential risk of an embolism to the patient. according to the manufacturer, there have been no reports of adverse patient events related to this issue. the manufacturer is voluntarily recalling and replacing all affected units of twin-pass, twin-pass rx and twin-pass .023”. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 september 2016.

Device

Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Vascular Solutions Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Manufacturer
    Vascular Solutions

Manufacturer

Vascular Solutions