Events

Safety Alert for REVISCULARIZATION DEVICE PENUMBRA - Registered in Anvisa under the number 80102510509 - Serial Numbers: F13242; F14138; F15141; F13607; F13801; F14346; F15105; F15150; F13901; F14842; F15173.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.

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
    996
  • Date
    2009-11-03
  • 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 manufacturer received a total of six complaints that identified the wire core breaking of separator 032 and 041 (3 events per size). Two of these events identified a total breakage of the wire core with the irreversible distal tip. For all other events, the tab was fully recovered because the secondary wire did not break and the procedures were completed successfully with the additional devices. A break occurred near the bulb (7.5 cm from the distal tip), while the other 5 involved separation of the distal tip. The occurrences occurred in Germany and the United Kingdom. There are no reports of occurrences in Brazil and the present moment.
  • Reason
    The manufacturer states that the aforementioned catheters and separators may partially or totally separate their rods if it is repeatedly and with application of compressive force against a firm obstruction while the apparatus is released by a guide catheter. the manufacturer has updated the instructions manual for the product since july 29, 2009.
  • Action
    Users are advised to carefully observe the instructions for use, especially with regard to: (1) Do not advance or use any component of the Penumbra System against resistance without careful evaluation of the cause using fluoroscopy. (2) If the cause can not be determined, remove the device. (3) Forced insertion of the catheter or separator against resistance may result in compression of the device which may lead to vessel damage and / or tip rupture.

Device

REVISCULARIZATION DEVICE PENUMBRA - Registered in Anvisa under the number 80102510509 - Serial Nu...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda
  • Source
    ANVSANVISA