Events

Safety Alert for Imager II Angiographic Catheters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-12-23
  • Event Date Posted
    2016-12-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161223c.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific imager ii angiographic catheters medical device manufacturer, boston scientific, has issued two medical device safety alerts (a product advisory and a medical device removal) concerning its imager ii angiographic catheters. the details of the affected device are as follows:- product advisory: material number (upn): multiple lot/batch number: multiple expiration date: 01 april 2018 to 31 july 2018 medical device removal: material number (upn): m001314141 (5-pack outer package upn); m001314140 (single unit, inner package upn) lot/batch number: 00112758 expiration date: may 11, 2018 the manufacturer is initiating a product advisory of a subset of imager ii angiographic catheters and a medical device removal of a single lot (00112758) of imager ii angiographic catheters. following a field report, the manufacturer 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. the manufacturer has confirmed that only one batch was missing a bottom seal, as a precautionary measure, the manufacturer is notifying all customers of this issue that received batches processed through this alternate label reprint process. affected users of the captioned upn (m001314141 and m001314140) and lot (00112758) should immediately discontinue use of such product and segregate it for product removal. if other affected users have identified any inventory missing a bottom pouch seal, the same action should be taken. 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. 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 23 december 2016.

Device

Imager II Angiographic Catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheters
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH