Events

Field Safety Notices about Chariot™ Guiding Sheath

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Boston Scientific International S.A..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-12-17
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    In the previous notification sent on 27 november 2015, boston scientific advised that it is recalling its chariot™ guiding sheath. to date, boston scientific has received fourteen complaints for shaft separation, four of which involved separation of the distal shaft. these events occurred during device preparation or use. .

Device

Chariot™ Guiding Sheath
  • Model / Serial
    H74939277645110 H74939277690210 H74939277690220 H74939277845210 H74939277745210 H74939277645210 H74939277745110 H74939277665110 H74939277690110 H74939277765110 H74939277545110 H74939277690120 H74939277845110 H74939277790110 H74939277865110 H74939277545210 H74939277790220 H74939277665120 H74939277645220 H74939277645120
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific International S.A.

Manufacturer

Boston Scientific International S.A.
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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
    AMPMDRS