Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by BIOTRONIK UK Ltd.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 079 05 11 000
  • Event Initiated Date
    2011-05-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=441
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    Complaints regarding deflation/ withdrawal difficulties with specific lots of passeo 18 balloon catheter. it was observed that the balloon of the affected passeo-18 balloon catheter was compacted at the distal end, leading to an increased fricition during withdrawal of the device. in some instances it was reported that he deflated balloon catheter could not be withdrawn through the introducer.

Device

Passeo peripheral balloon catheter
  • Model / Serial
    Passeo-18 balloon catheter. Specific lots with balloon diameter Ø 2.5- 4.0 mm.
  • Product Description
    Catheters, Vascular, Angioplasty, Balloon, Coronary Perfusion
  • Manufacturer
    BIOTRONIK UK Ltd

Manufacturer

BIOTRONIK UK Ltd
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA