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:

• Only use appropriately sized percutaneous transluminal angioplasty (PTA) balloons during all intervention procedures for a thrombosed fistula.
• Use a maximum 3mm diameter balloon across the anastomosis for any planned PTA balloon interventions of patients with a 3mm Optiflow.
• Use a maximum 4mm diameter balloon across the anastomosis for any planned PTA balloon interventions with patients with a 4mm Optiflow.
• Carefully follow the Instructions For Use for the PTA balloon and do not to advance or retract the balloon unless the balloon is fully deflated.
• When advancing or retracting a compliant balloon across the anastomosis ensure the inflated balloon diameter is not greater than 4mm for the 4mm Optiflow or 3mm for the 3mm Optiflow

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