Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Cosman Medical Nitinol RF (TCN) Reusable Electrodes. The TCN Electrodes were manufactured by Cosman Medical, a wholly-owned subsidiary of Boston Scientific, and affected units are labeled as Cosman. The affected products are TCN-5, TCN-15-3M, TCNK-5-R, TCNK-15-C, TCN-5-3M, TCN-20, TCNK-10, TCNK-15-R, TCN-10, TCN-20-3M, TCNK-10-C, TCNK-20, TCN-10-3M, TCNK-5, TCNK-10-R, TCNK-20-C, TCN-15, TCNK-5-C, TCNK-15 and TCNK-20-R.

According to the manufacturer, there have been complaints that after multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device. The failure to completely remove any blood and/or tissue from the TCN Electrodes prior to re-sterilization creates a potential risk of infection and spread of blood borne pathogens to patients. The manufacturer has not received any reports of patient injury related to this issue. Cosman stainless steel (CSK) and Disposable (TCD/CU/CUR) Electrodes are not affected by this action.

The manufacturer advises users to take the following actions:

• If users have any of these affected electrodes within their inventory that have not been used, segregate the product immediately. Unused/un-opened TCN Electrodes should be identified as single use only (for one patient). These devices are supplied as non-sterile which require cleaning and sterilization prior to use. These TCN Electrodes may be used once the cleaning and sterilization steps are completed. After single use, the used TCN Electrode should be disposed of in accordance with their institution's infectious material/biohazard waste control procedures.
• Used TCN Electrodes should be disposed immediately in accordance with their institution's infectious material/biohazard waste control procedures. Users should immediately discontinue use of devices that have already been used.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 7 July 2017