Events

Field Safety Notices about Ebb Complete Tamponade System (CTS-lOOO)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Clinical Innovations LLC .

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-07-09
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    This is to inform you of a voluntary global recall of clinical innovations’ ebb complete tamponade system (cts- 1000) involving lot numbers 1214—v-424; 1214-f-403 .The purpose of the recall is to address the potential for a balloon leak which may affect your ability to deliver therapy, when needed. clinical innovations’ records indicate you have received a product that is affected by this action. following a report that an ebb complete tamponade system (cts-looo) had leaked during use, clinical innovations conducted an investigation on the returned device and concluded that the leakage was caused by a failure mode of the bond at distal end of the uterine balloon a balloon leak can be identified by a failure to arrest bleeding, ultrasound revealing loss of balloon volume, or blood-tinged liquid being expelled from the drainage tube. a uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention. although unlikely, death could occur due to the failure mode associated with this recall. in the report received, the patient had stabilized prior to the leak being noticed by the clinical team. because there is a potential for additional interventions with a balloon leak (such as arterial embolization or surgery) required to control a postpartum hemorrhage, we are requesting that you return all unused ebb complete tamponade system (cts-looo) from the above—listed lot numbers. no other clinical innovations products are affected by this issue.

Device

Ebb Complete Tamponade System (CTS-lOOO)

Manufacturer

Clinical Innovations LLC