Events

Field Safety Notices about Imager™ II Angiographic

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
    2016-12-19
  • 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
    Boston scientific is initiating a field safety notice for a subset of imager™ ii angiographic catheters. following a field report, boston scientific has determined that some units within a single lot were missing the bottom pouch seal. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. although boston scientific has confirmed that only one batch was missing a bottom seal, as a precautionary measure, we are notifying all customers of this issue that received batches processed through this alternate label reprint process. the compromised seal is completely missing and is obvious to the user. the device can be readily exchanged resulting in an insignificant prolongation in procedure. to date there have been no reports of patient injury associated with a missing pouch seal. .

Device

Imager™ II Angiographic

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