Events

Safety Alert for Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa registration No. 10339190532. Products affected: AMD015020002 AMD020120152 AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD015020151 AMD020150002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD015020152 AMD020150152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD020040002 AMD025040152 AMD030080002 AMD035150002 AMD040150152 AMD354210152. AMD020040152 AMD025080152 AMD030080152 AMD035150152 AMD225210002. AMD0200120002 AMD025120002 AMD030120002 AMD040040152 AMD225210152. AMD0200160152 AMD025120152 AMD030120152 AMD040080002 AMD253210002. AMD02012002 AMD025150002 AMD030150002 AMD040080152 AMD253210152 ... #### UPDATE (01/14/2016): According to the company, all the codes of the products affected globally were erroneously reported, but in Brazil only one code was affected (AMD225210152), of which only 03 lots are under risk - 209532760, 209507756 and 209507757. The above list (see above) does not therefore apply in its entirety to Brazil.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA; INVATEC S.p.A..

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
    1749
  • Date
    2015-11-20
  • 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
    The potential for rupture in the pouch containing the sterilized product was discovered by Medtronic during in-house packaging testing, which involves exposure to extreme conditions of use. Rupture of the pouch seal may potentially result in compromised product sterility. Patients who received treatment with an Amphirion® Deep Catheter Dilatation Balloon for ATP affected by this recall should continue to be monitored according to their standard practice. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • Reason
    This recall was initiated because of a potential breach of the bag sealing for the products manufactured in these selected lots.
  • Action
    The product is being collected by the company. Segregate the products in inventory, identifying them to avoid inadvertent use and contact the responsible company or distributor. Company code for the field action: FA684.

Device

Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa regist...

Manufacturer

MEDTRONIC COMERCIAL LTDA; INVATEC S.p.A.
  • 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