Events

Safety Alert for Nit-Occlud Implantation Sheath

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

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
    2017-11-21
  • Event Date Posted
    2017-11-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171121.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: pfm medical nit-occlud implantation sheath the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has posted a medical device safety alert concerning nit-occlud implantation sheath, manufactured by pfm medical ag. the affected devices are identified as follows:- product names: a) implantation sheath, 10f, 45°, 80cm; b) implantation sheath, 12f, 45°, 80cm; c) implantation sheath, 12f, 45°,80cm; d) implantation sheath, 14f, 45°, 80cm; e) implantation sheath, 6f, 45°, 80cm; f) implantation sheath, 8f, 45°, 80cm; g) implantation sheath, 9f, 45°, 80cm reference numbers: a) 004580; b) 204580; c) 204580; d) 404580; e) 604580; f) 804580; g) 904580 the manufacturer has received feedback from the outside european community that in individual cases the atraumatic tip (soft tip) of the nit-occlud implantation sheath detached during preparation and application under incorrect storage conditions (discoloration of the sterile packaging). according to the manufacturer, the sheaths are being used to get access to the vessel system. particles from the tip of the sheath therefore might embolize in the vessel system and as a result impede or stop the blood flow. particles in the venous system could cause a pulmonary embolism or thrombosis. embolizing particles in the arterial system could possibly result in infarction on all organ systems with tissue death (necrosis) and could result in heart attack and stroke. this can in the worst case lead to irreversible organ damage up to death the manufacturer has not received any information so far that the products have quality problems when properly stored and used. however, due to the high potential risk of detachment, the manufacturer decided to recall the affected devices as a precaution in order to investigate them systematically. for further details including the affected lot numbers, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-13-to-17-november-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 november 2017.

Device

Nit-Occlud Implantation Sheath
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: PFM Medical Nit-Occlud Implantation Sheath
  • Manufacturer
    PFM Medical AG

Manufacturer

PFM Medical AG