Events

Safety Alert for VENTURA Hydrocephalus Implant Valve

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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
    R1709-455
  • Event Number
    2015DM-0013522 ; 2015DM-0013521
  • Date
    2017-09-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data

Device

VENTURA Hydrocephalus Implant Valve
  • Model / Serial
  • Product Description
    Valves for hydrocephalus are implant devices used in the surgical treatment of hydrocephalus, to derive the CSF (cerebrospinal fluid) from the ventricles into the peritoneal cavity or to other drainage sites appropriate for a particular patient. Sondispositives produced in medical grade silicones and material-thermoplastic with unrestricted implantability, intended for use in patients with hydrocephalus. The external ventricular drainage catheter with anti-siphon mechanism (CSF "cerebrospinal fluid" / MAS "anti-siphon mechanism") is indicated in temporary relief of intracranial hypertension for any etiology that causes a disturbance in the absorption of the flow of CLL, whether in subarachnoid hemorrhages, interventricular, hydrocephalus, and primary brain tumors. The anti-siphon mechanism has an internal design, which allows the LCR to flow inside without offering additional resistance to the drainage system, and when a negative pressure occurs in the distal part of the system (fall of the bag to the floor, for example), the The anti-siphon mechanism is activated and blocks the sudden emptying of the cerebral ventricles. The external drainage systems are used to drain the cerebrospinal fluid (produced inside the cerebral ventricles) into a collecting container located externally of the human body. These systems are relatively widely used in neurosurgical procedures and, in general, are composed of a
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA