The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter, manufactured by Biosense Webster.

The manufacturer has identified a higher frequency of spontaneously reported adverse events related to cardiac perforations and atrio-esophageal fistula (AEF) with the uni-directional and bi-directional THERMOCOOL SF NAV Catheter Family during the time period of January 2010 to December 2013 as compared to other navigational THERMOCOOL Ablation Catheters.

The manufacturer has not yet identified a definitive cause for this observed difference in frequency of adverse events for the uni-directional and bi-directional THERMOCOOL SF NAV Catheter Family. Meanwhile, the manufacturer advises that two factors should be considered in relation to these reported adverse events:

• The increased stiffness and the related handling properties of the THERMOCOOL SF NAV Catheter Family may contribute to the risk for perforation.
• Due to the enhanced cooling feature of the THERMOCOOL SF NAV Catheter, application of the same power settings, guided by temperature feedback, as previously used with other navigational THERMOCOOL Catheters may result in relatively deeper lesions and potentially contributes to higher rate of AEF and cardiac perforations.

The manufacturer also reminds users to pay special attention on relevant Warnings and Precautions in the Instructions for Use (IFU) for the THERMOCOOLSF NAV Catheter Family models.

According to the local supplier, Johnson & Johnson (Hong Kong) Ltd, the affected products were distributed in Hong Kong.

For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON402544

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 15 April 2014