Events

Alerte De Sécurité sur Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit

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

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
    2015-03-04
  • Date de publication de l'événement
    2015-03-04
  • 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_20150304.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: boston scientific expel drainage catheter with twist-loc hub and biliary drainage catheter kit medical device manufacturer, boston scientific, has issued a medical device safety alert concerning the following drainage catheters: expel drainage catheter with twist-loc hub and biliary drainage catheter kit expel drainage catheter with twist-loc hub apdl drainage catheter and apdl drainage catheter kit expel drainage catheter apd drainage catheter expel large capacity drainage catheter apd large capacity drainage catheter the manufacturer has received one complaint (expel apd) and 11 complaints (expel drainage catheter with twist-loc hub and biliary drainage catheter kit) of device fragmentation after the catheter was implanted in the biliary system. according to the manufacturer, the most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods. the manufacturer advises affected users of the following:- do not use the expel apd and apdl drainage catheters for bile drainage. other than for bile drainage, affected users may continue to use the expel apd and apdl drainage catheters according to the directions for use. the expel drainage catheter with twist-loc hub nephrostomy drainage catheter and nephrostomy drainage catheter kit are not indicated for use in the biliary system and these devices must be used in a manner that is consistent with the device’s directions for use. the expel apd, apdl, nephrostomy drainage catheters are not being retrieved and must not be used for bile drainage. further distribution or use of any remaining unused products should cease immediately. for biliary catheters that are already implanted, physicians should monitor their patients following their judgment and standard of care. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 march 2015.

Device

Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH