The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Optiflow Anastomotic Connector manufactured by Bioconnect Systems. The affected catalogue numbers are CS3203, CS4204 and CS4205.
According to the manufacturer, the Optiflow Anastomotic Connector may be inadvertently dislodged (moved from the intended position) during Percutaneous Balloon Assisted Interventions to open a thrombosed fistula. The Optiflow may get caught on or attached to the balloon if the balloon is not fully deflated during the interventional procedure. The Optiflow may then dislodge or move during advancement or retraction of the balloon.
The manufacturer supplemented that Optiflow dislodgement may result in serious injury or death to the patient if the Optiflow is not captured and removed following inadvertent dislodgement as it may travel through the upper venous circulatory system, the heart and into the pulmonary circulatory system.
To prevent possible dislodgement of the Optiflow Anastomotic Connector, Bioconnect advised all customers to:
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 22 August 2012