Events

Safety Alert for Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERIPHERAL ANGIOPLASTY ANVISA Registration Number: 10349000474 Hazard Class: II Affected Model: AB18W030200150

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AUTO SUTURE DO BRASIL LTDA; ev3 Inc..

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
  • Event ID
    2120
  • Date
    2016-08-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    There is no need for action with the patient. Patients who received treatment with an OTW Dilatation Catheter for 0.018 "PowerCross ™ PTA affected by this recall should continue to be monitored according to standard practice.
  • Reason
    Auto suture is conducting a voluntary recall of two lots of otw dilatation catheter for pta powercross ™ 0.018 ". this recall was initiated for model ab18w030200150 and is limited to lot numbers a213373 and a216702. this voluntary recall is being initiated due to the identification of a divergence in the description of the size of the balloon. where these affected units, which have a true size of the 3 x 200 mm balloon, are incorrectly marked on the product itself, specifically in the area of ​​tension relief, such as 2.5 x 150 mm (as shown in the enclosed customer letter ). the correct labeling (3 x 200 mm) for the actual size of the balloon is included in the outer carton as well as the inner packaging of the affected devices.
  • Action
    Field Action Code FA Recall PowerCross triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company will collect for further destruction.

Device

Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERI...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; ev3 Inc.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA